Article(id=1194617493185601725, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1194617490446721194, articleNumber=null, orderNo=null, doi=10.11855/j.issn.0577-7402.1632.2024.0711, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1702137600000, receivedDateStr=2023-12-10, revisedDate=null, revisedDateStr=null, acceptedDate=1704643200000, acceptedDateStr=2024-01-08, onlineDate=1762748605294, onlineDateStr=2025-11-10, pubDate=1740672000000, pubDateStr=2025-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1762748605294, onlineIssueDateStr=2025-11-10, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1762748605294, creator=13701087609, updateTime=1762748605294, updator=13701087609, issue=Issue{id=1194617490446721194, tenantId=1146029695717560320, journalId=1189873630562394117, year='2025', volume='50', issue='2', pageStart='123', pageEnd='244', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1762748604641, creator=13701087609, updateTime=1762749162199, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1194619829073191185, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1194617490446721194, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1194619829073191186, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1194617490446721194, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=141, endPage=145, ext={EN=ArticleExt(id=1194617493437259968, articleId=1194617493185601725, tenantId=1146029695717560320, journalId=1189873630562394117, language=EN, title=Determination of median effective dose of remimazolam for preoperative sedation in pediatric patients, columnId=1190310109000602400, journalTitle=Medical Journal of Chinese People’s Liberation Army, columnName=Clinical Research, runingTitle=null, highlight=null, articleAbstract=

Objective To determine the median effective dose (ED50) of remimazolam for preoperative sedation in pediatric patients aged 1-6 years using the modified Dixon sequential method. Methods This is a prospective clinical study. Pediatric patients scheduled for elective short surgery (surgery time ≤1 h) under general anesthesia from January to July 2023 were selected. Inclusion criteria were age 1-6 years, an ASA physical status Ⅰ-Ⅱ and the preoperative parent separation anxiety scale (PSAS) score ≥3 points. Remimazolam was administered intravenously preoperatively, and its sedative effect was assessed. The modified Dixon sequential method was used to determine the ED50 of remimazolam, with the initial dose set at 0.10 mg/kg and the dose increment set at 0.02 mg/kg. Sedation was considered successful (positive, included in positive group) if the child with sedation score ≥2 points, preoperative PSAS score <3 points,and the mask acceptance score of 4 points during anesthesia induction. If any criterion was not met, sedation was considered failure (negative, included in negative group), and the next patient's dosage was increased by 0.02 mg/kg based on the previous patient's dosage. The test was completed after 7 consecutive positive and negative turning points appeared alternately. Probabilistic unit regression analysis was used to determine the ED50, ED95 and the corresponding 95% confidence interval (CI) of remimazolam for preoperative sedation. Postoperative recovery time and adverse events such as airway spasm, respiratory depression, hypotension, nausea and vomiting during anesthesia were recorded. Results A total of 23 pediatric patients were included, with 13 in positive group and 10 in negative group. There were no statistically significant differences in mean arterial pressure, pulse oxygen saturation or heart rate before and after sedation (P>0.05). Compared with negative group, positive group showed a significant reduction in preoperative parent separation anxiety and an increase in mask acceptance during anesthesia (P<0.05). There was no significant difference in sedation score and anesthesia awakening time between two groups (P>0.05). The ED50 of remimazolam for preoperative sedation in pediatric patients aged 1-6 years was 0.051 mg/kg (95%CI 0.033-0.065 mg/kg), and the ED95 was 0.077 mg/kg (95%CI 0.064-0.161 mg/kg). No adverse events such as airway spasm, respiratory depression, hypotension, nausea and vomiting occurred during anesthesia in any of pediatric patients. Conclusion The ED50 of intravenous administration of remimazolam for preoperative sedation in pediatric patients aged 1-6 years is 0.051 mg/kg (95%CI 0.033-0.065 mg/kg).

, correspAuthors=Ning Cai, authorNote=null, correspAuthorsNote=
E-mail:
, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Mei-Chao Wu, Fang-Fang Yang, Chen-Xu Dai, Xing-Jun Ma, Ning Cai), CN=ArticleExt(id=1194617624492483321, articleId=1194617493185601725, tenantId=1146029695717560320, journalId=1189873630562394117, language=CN, title=瑞马唑仑对小儿术前镇静的半数有效剂量分析, columnId=1190310109164180259, journalTitle=解放军医学杂志, columnName=临床研究, runingTitle=null, highlight=null, articleAbstract=

目的 采用改良Dixon序贯法确定瑞马唑仑用于1~6岁患儿术前镇静的半数有效剂量(ED50)。方法 本研究为前瞻性临床研究。纳入2023年1-7月在阜阳市人民医院择期行全身麻醉下短小手术(手术时间≤1 h)的小儿患者。纳入标准为:年龄1~6岁,美国麻醉医师协会(ASA)健康状况分级Ⅰ-Ⅱ级,术前父母分离焦虑量表(PSAS)评分≥3分。术前静脉注射瑞马唑仑并对镇静效果进行评估,采用改良Dixon序贯法确定其ED50,首例初始剂量设置为0.10 mg/kg,剂量梯度设置为0.02 mg/kg,当患儿镇静评分≥2分、术前PSAS评分<3分且麻醉诱导时面罩接受程度评分为4分时认定镇静成功(阳性,纳入阳性组),后一例患儿在前一例患儿用药量的基础上减少0.02 mg/kg,当任何一个指标评分达不到设定标准时则认定镇静失败(阴性,纳入阴性组),后一例患儿在前一例患儿用药量基础上增加0.02 mg/kg,当连续有7个阳性、阴性拐点交替显现后结束研究。采用概率单位回归分析(Probit)法确定瑞马唑仑术前镇静剂量的ED50、ED95及95%可信区间(CI)。记录患儿手术结束后的麻醉苏醒时间及麻醉期间气道痉挛、呼吸抑制、低血压、恶心呕吐等不良反应的发生情况。结果 共纳入患儿23例,其中阳性组13例,阴性组10例。所有患儿镇静前后平均动脉压、心率、血氧饱和度比较差异均无统计学意义(P>0.05)。与阴性组比较,阳性组患儿术前父母分离焦虑程度降低,麻醉诱导时面罩接受程度增高,差异有统计学意义(P<0.05);两组镇静评分及麻醉清醒时间比较差异均无统计学意义(P>0.05)。瑞马唑仑用于1~6岁患儿术前镇静的ED50为0.051 mg/kg(95%CI 0.033~0.065 mg/kg),ED95为0.077 mg/kg(95%CI 0.064~0.161 mg/kg)。所有患儿麻醉期间均未出现气道痉挛、呼吸抑制、低血压、恶心呕吐等不良反应。结论 瑞马唑仑静脉注射用于1~6岁患儿术前镇静的ED50为0.051 mg/kg(95%CI 0.033~0.065 mg/kg),且具有良好的可控性及安全性。

, correspAuthors=蔡宁, authorNote=null, correspAuthorsNote=
蔡宁,E-mail:
, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=a+YeOjCfwkIkKC8XDXJRWg==, magXml=W/mm2RaUuZqqvuf3kkOkhw==, pdfUrl=null, pdf=Ci+A1FES0Xm+Rk9HyLIdzw==, pdfFileSize=981227, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=k1IxT8IEGZaqp+N2YMUX2w==, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=USi+lYGTyToh+80mNMxLuA==, mapNumber=null, authorCompany=null, fund=null, authors=

吴美潮,硕士研究生,主治医师,主要从事小儿麻醉、骨科麻醉、区域阻滞麻醉等方面的临床研究

, authorsList=吴美潮, 杨芳芳, 代晨旭, 马行军, 蔡宁)}, authors=[Author(id=1194650232932766229, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1194650233008263703, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, authorId=1194650232932766229, language=EN, stringName=Mei-Chao Wu, firstName=Mei-Chao, middleName=null, lastName=Wu, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1194650233066983960, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, authorId=1194650232932766229, language=CN, stringName=吴美潮, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=阜阳市人民医院麻醉科,安徽阜阳 236000, bio={"content":"

吴美潮,硕士研究生,主治医师,主要从事小儿麻醉、骨科麻醉、区域阻滞麻醉等方面的临床研究

"}, bioImg=null, bioContent=

吴美潮,硕士研究生,主治医师,主要从事小儿麻醉、骨科麻醉、区域阻滞麻醉等方面的临床研究

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1194650232836297233, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, xref=null, ext=[AuthorCompanyExt(id=1194650232844685842, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China), AuthorCompanyExt(id=1194650232857268755, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=阜阳市人民医院麻醉科,安徽阜阳 236000)])]), Author(id=1194650233146675738, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1194650233222173212, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, authorId=1194650233146675738, language=EN, stringName=Fang-Fang Yang, firstName=Fang-Fang, middleName=null, lastName=Yang, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1194650233280893469, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, authorId=1194650233146675738, language=CN, stringName=杨芳芳, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=阜阳市人民医院麻醉科,安徽阜阳 236000, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1194650232836297233, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, xref=null, ext=[AuthorCompanyExt(id=1194650232844685842, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China), AuthorCompanyExt(id=1194650232857268755, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=阜阳市人民医院麻醉科,安徽阜阳 236000)])]), Author(id=1194650233331225119, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1194650233419305505, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, authorId=1194650233331225119, language=EN, stringName=Chen-Xu Dai, firstName=Chen-Xu, middleName=null, lastName=Dai, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1194650233482220066, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, authorId=1194650233331225119, language=CN, stringName=代晨旭, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=阜阳市人民医院麻醉科,安徽阜阳 236000, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1194650232836297233, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, xref=null, ext=[AuthorCompanyExt(id=1194650232844685842, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China), AuthorCompanyExt(id=1194650232857268755, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=阜阳市人民医院麻醉科,安徽阜阳 236000)])]), Author(id=1194650233549328932, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1194650233645797926, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, authorId=1194650233549328932, language=EN, stringName=Xing-Jun Ma, firstName=Xing-Jun, middleName=null, lastName=Ma, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1194650233759044135, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, authorId=1194650233549328932, language=CN, stringName=马行军, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=阜阳市人民医院麻醉科,安徽阜阳 236000, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1194650232836297233, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, xref=null, ext=[AuthorCompanyExt(id=1194650232844685842, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China), AuthorCompanyExt(id=1194650232857268755, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=阜阳市人民医院麻醉科,安徽阜阳 236000)])]), Author(id=1194650233838735913, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=cn0049@163.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1194650234933449259, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, authorId=1194650233838735913, language=EN, stringName=Ning Cai, firstName=Ning, middleName=null, lastName=Cai, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=*, address=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1194650235029918252, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, authorId=1194650233838735913, language=CN, stringName=蔡宁, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=*, address=阜阳市人民医院麻醉科,安徽阜阳 236000, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1194650232836297233, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, xref=null, ext=[AuthorCompanyExt(id=1194650232844685842, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China), AuthorCompanyExt(id=1194650232857268755, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=阜阳市人民医院麻醉科,安徽阜阳 236000)])])], keywords=[Keyword(id=1194650235164135981, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=EN, orderNo=1, keyword=remimazolam), Keyword(id=1194650235227050542, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=EN, orderNo=2, keyword=pediatric patient), Keyword(id=1194650235281576495, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=EN, orderNo=3, keyword=preoperative sedation), Keyword(id=1194650235340296752, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=EN, orderNo=4, keyword=modified sequential method), Keyword(id=1194650235466125873, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=EN, orderNo=5, keyword=dose-effect relationship), Keyword(id=1194650235524846130, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=CN, orderNo=1, keyword=瑞马唑仑), Keyword(id=1194650235587760691, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=CN, orderNo=2, keyword=患儿), Keyword(id=1194650235646480948, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=CN, orderNo=3, keyword=术前镇静), Keyword(id=1194650235705201205, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=CN, orderNo=4, keyword=改良序贯法), Keyword(id=1194650235759727158, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=CN, orderNo=5, keyword=剂量-效应关系)], refs=[Reference(id=1194650236795720257, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2021, volume=101, issue=26, pageStart=2066, pageEnd=2070, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=王月, 初丽艳, 王珊珊, journalName=中华医学杂志, refType=null, unstructuredReference=王月, 初丽艳, 王珊珊, 等. 术前动画视频陪伴改善学龄前儿童分离焦虑及诱导配合的临床观察[J]. 中华医学杂志, 2021, 101(26): 2066-2070., articleTitle=术前动画视频陪伴改善学龄前儿童分离焦虑及诱导配合的临床观察, refAbstract=null), Reference(id=1194650236875412034, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2017, volume=104, issue=12, pageStart=1628, pageEnd=1633, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=Ryu JH, Park SJ, Park JW, journalName=Br J Surg, refType=null, unstructuredReference=Ryu JH, Park SJ, Park JW, et al. Randomized clinical trial of immerse vevirtual reality tour of the operating theatre in children before anaesthesia[J]. Br J Surg, 2017, 104(12): 1628-1633., articleTitle=Randomized clinical trial of immerse vevirtual reality tour of the operating theatre in children before anaesthesia, refAbstract=null), Reference(id=1194650236946715203, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2015, volume=41, issue=2, pageStart=182, pageEnd=203, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=Chow CHT, Van Ieshout RJ, Schmidt LA, journalName=J Pediatr Psychol, refType=null, unstructuredReference=Chow CHT, Van Ieshout RJ, Schmidt LA, et al. Systematic review: audiovisual interventions for reducing preoperative anxiety in children undergoing elective surgery[J]. J Pediatr Psychol, 2015, 41(2): 182-203., articleTitle=Systematic review: audiovisual interventions for reducing preoperative anxiety in children undergoing elective surgery, refAbstract=null), Reference(id=1194650237013824068, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2021, volume=21, issue=1, pageStart=336, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=3, authorNames=Li B, Hou H, Bai J, journalName=BMC Pediatr, refType=null, unstructuredReference=Li B, Hou H, Bai J, et al. Paediatric preoperative sedation practices in tertiary maternity and children' shospitals in China: a questionnaire survey[J]. BMC Pediatr, 2021, 21(1): 336., articleTitle=Paediatric preoperative sedation practices in tertiary maternity and children' shospitals in China: a questionnaire survey, refAbstract=null), Reference(id=1194650237097710149, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2021, volume=36, issue=4, pageStart=1219, pageEnd=1225, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=Van Den Bosch OFC, Alvarez-Jimenez R, Schet SG, journalName=J Clin Monit Comput, refType=null, unstructuredReference=Van Den Bosch OFC, Alvarez-Jimenez R, Schet SG, et al. Breathing variability during propofol/remifentanil procedural sedation with a single additional dose of midazolam or s-ketamine: a prospective observational study[J]. J Clin Monit Comput, 2021, 36(4): 1219-1225., articleTitle=Breathing variability during propofol/remifentanil procedural sedation with a single additional dose of midazolam or s-ketamine: a prospective observational study, refAbstract=null), Reference(id=1194650237169013318, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2024, volume=49, issue=10, pageStart=1105, pageEnd=1109, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=李森, 蓝金辛, 杨铎, journalName=解放军医学杂志, refType=null, unstructuredReference=李森, 蓝金辛, 杨铎, 等. 瑞马唑仑对重要器官的保护作用[J]. 解放军医学杂志, 2024, 49(10): 1105-1109., articleTitle=瑞马唑仑对重要器官的保护作用, refAbstract=null), Reference(id=1194650237223539271, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2020, volume=66, issue=null, pageStart=109899, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=Zhou J, Leonowens C, Ivaturi VD, journalName=J Clin Anesth, refType=null, unstructuredReference=Zhou J, Leonowens C, Ivaturi VD, et al. Population pharmaco-kinetic/pharmacodynarnic modeling for remimazolam in the induction and maintenance of general anesthesia in healthy subjects and in surgical subjects[J]. J Clin Anesth, 2020, 66: 109899., articleTitle=Population pharmaco-kinetic/pharmacodynarnic modeling for remimazolam in the induction and maintenance of general anesthesia in healthy subjects and in surgical subjects, refAbstract=null), Reference(id=1194650237282259528, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2023, volume=14, issue=null, pageStart=1090608, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=Fang YB, Wang CY, Gao YQ, journalName=Front Pharmacol, refType=null, unstructuredReference=Fang YB, Wang CY, Gao YQ, et al. The safety and efficacy of remimazolam tosylate for induction and maintenance of general anesthesia in pediatric patients undergoing elective surgery: study protocol for a multicenter, randomized, single-blind, positive-controlled clinical trial[J]. Front Pharmacol, 2023, 14: 1090608., articleTitle=The safety and efficacy of remimazolam tosylate for induction and maintenance of general anesthesia in pediatric patients undergoing elective surgery: study protocol for a multicenter, randomized, single-blind, positive-controlled clinical trial, refAbstract=null), Reference(id=1194650237345174089, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2022, volume=8, issue=1, pageStart=66, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=Kamata K, Asagi S, Shimoda Y, journalName=JA Clinical Reports, refType=null, unstructuredReference=Kamata K, Asagi S, Shimoda Y, et al. Successful recording of direct cortical motor-evoked potential from a pediatric patient under remimazolam anesthesia: a case report[J]. JA Clinical Reports, 2022, 8(1): 66., articleTitle=Successful recording of direct cortical motor-evoked potential from a pediatric patient under remimazolam anesthesia: a case report, refAbstract=null), Reference(id=1194650237437448778, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2021, volume=100, issue=49, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[10], rfOrder=9, authorNames=Horikoshi Y, Kuratani N, Tateno K, journalName=Medicine (Baltimore), refType=null, unstructuredReference=Horikoshi Y, Kuratani N, Tateno K, et al. Anesthetic management with remimazolam for a pediatric patient with Duchenne muscular dystrophy[J]. Medicine (Baltimore), 2021, 100 (49): e28209., articleTitle=Anesthetic management with remimazolam for a pediatric patient with Duchenne muscular dystrophy, refAbstract=null), Reference(id=1194650237508751947, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2021, volume=36, issue=1, pageStart=1, pageEnd=4, url=null, language=null, rfNumber=[11], rfOrder=10, authorNames=Shioji N, Everett T, Suzuki Y, journalName=J Anesth, refType=null, unstructuredReference=Shioji N, Everett T, Suzuki Y, et al. Pediatric sedation using dexmedetomidine and remimazolam for magnetic resonance imaging[J]. J Anesth, 2021, 36 (1): 1-4., articleTitle=Pediatric sedation using dexmedetomidine and remimazolam for magnetic resonance imaging, refAbstract=null), Reference(id=1194650237571666508, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2000, volume=null, issue=null, pageStart=114, pageEnd=136, url=null, language=null, rfNumber=[12], rfOrder=11, authorNames=王仁安, journalName=医学实验设计与统计分析, refType=null, unstructuredReference=王仁安. 医学实验设计与统计分析[M]. 北京: 北京医科大学出版社, 2000: 114-136., articleTitle=null, refAbstract=null), Reference(id=1194650237647163981, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2006, volume=50, issue=null, pageStart=27, pageEnd=31, url=null, language=null, rfNumber=[13], rfOrder=12, authorNames=Malde AD, Pagedar RA, Jagtap SR, journalName=Indian J Anaesth, refType=null, unstructuredReference=Malde AD, Pagedar RA, Jagtap SR. Oral clonidine in children: efficacy as premedicant and postoperative analgesic as compared to diazepam[J]. Indian J Anaesth, 2006, 50: 27-31., articleTitle=Oral clonidine in children: efficacy as premedicant and postoperative analgesic as compared to diazepam, refAbstract=null), Reference(id=1194650237705884238, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2022, volume=42, issue=3, pageStart=320, pageEnd=322, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=张贝贝, 杨倚天, 贾佳, journalName=中华麻醉学杂志, refType=null, unstructuredReference=张贝贝, 杨倚天, 贾佳, 等. 艾司氯胺酮用于不同年龄段患儿术前镇静的半数有效剂量[J]. 中华麻醉学杂志, 2022, 42(3): 320-322., articleTitle=艾司氯胺酮用于不同年龄段患儿术前镇静的半数有效剂量, refAbstract=null), Reference(id=1194650237772993103, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2022, volume=38, issue=2, pageStart=154, pageEnd=158, url=null, language=null, rfNumber=[15], rfOrder=14, authorNames=王小玲, 袁静静, 邢飞, journalName=临床麻醉学杂志, refType=null, unstructuredReference=王小玲, 袁静静, 邢飞, 等. 小剂量艾司氯胺酮对患儿扁桃体腺样体切除术全麻苏醒期躁动的影响[J]. 临床麻醉学杂志, 2022, 38(2): 154-158., articleTitle=小剂量艾司氯胺酮对患儿扁桃体腺样体切除术全麻苏醒期躁动的影响, refAbstract=null), Reference(id=1194650237835907664, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2010, volume=20, issue=4, pageStart=318, pageEnd=322, url=null, language=null, rfNumber=[16], rfOrder=15, authorNames=Fortier MA, Del Rosario AM, Martin SR, journalName=Pediatr Anesth, refType=null, unstructuredReference=Fortier MA, Del Rosario AM, Martin SR, et al. Perioperative anxiety in children[J]. Pediatr Anesth, 2010, 20(4): 318-322., articleTitle=Perioperative anxiety in children, refAbstract=null), Reference(id=1194650237894627921, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2021, volume=10, issue=11, pageStart=2941, pageEnd=2951, url=null, language=null, rfNumber=[17], rfOrder=16, authorNames=Bian Y, Zhou S, Hou H, journalName=Transl Pediatr, refType=null, unstructuredReference=Bian Y, Zhou S, Hou H, et al. The optimal dose of oral midazolam with or without intranasal S-ketamine for premedication in children: a randomised, double blinded, sequential dose-finding trial[J]. Transl Pediatr, 2021, 10(11): 2941-2951., articleTitle=The optimal dose of oral midazolam with or without intranasal S-ketamine for premedication in children: a randomised, double blinded, sequential dose-finding trial, refAbstract=null), Reference(id=1194650237949153874, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2021, volume=31, issue=11, pageStart=1225, pageEnd=1233, url=null, language=null, rfNumber=[18], rfOrder=17, authorNames=Bromfalk Å, Myrberg T, Walldén J, journalName=Pediatr Anesth, refType=null, unstructuredReference=Bromfalk Å, Myrberg T, Walldén J, et al. Preoperative anxiety in preschool children: a randomized clinical trial comparing midazolam, clonidine, and dexmedetomidine[J]. Pediatr Anesth, 2021, 31(11): 1225-1233., articleTitle=Preoperative anxiety in preschool children: a randomized clinical trial comparing midazolam, clonidine, and dexmedetomidine, refAbstract=null), Reference(id=1194650238024651347, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2020, volume=32, issue=3-4, pageStart=325, pageEnd=333, url=null, language=null, rfNumber=[19], rfOrder=18, authorNames=Mihaljevic S, Pavlovic M, Reiner K, journalName=Psychiatr Danub, refType=null, unstructuredReference=Mihaljevic S, Pavlovic M, Reiner K, et al. Therapeutic mechanisms of ketamine[J]. Psychiatr Danub, 2020, 32(3-4): 325-333., articleTitle=Therapeutic mechanisms of ketamine, refAbstract=null), Reference(id=1194650238095954516, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2021, volume=15, issue=null, pageStart=4551, pageEnd=4558, url=null, language=null, rfNumber=[20], rfOrder=19, authorNames=Guan XH, Jiao Z, Gong XF, journalName=Drug Des Devel Ther, refType=null, unstructuredReference=Guan XH, Jiao Z, Gong XF, et al. Efficacy of pretreatment with remimazolam on prevention of propofol-induced injection pain in patients undergoing abortion or curettage: a prospective, double-blinded, randomized and placebo-controlled clinicaltrial[J]. Drug Des Devel Ther, 2021, 15: 4551-4558., articleTitle=Efficacy of pretreatment with remimazolam on prevention of propofol-induced injection pain in patients undergoing abortion or curettage: a prospective, double-blinded, randomized and placebo-controlled clinicaltrial, refAbstract=null), Reference(id=1194650238158869077, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2021, volume=8, issue=null, pageStart=735473, pageEnd=null, url=null, language=null, rfNumber=[21], rfOrder=20, authorNames=Liu SJ, Su LX, Zhang B, journalName=Front Med (Lausanne), refType=null, unstructuredReference=Liu SJ, Su LX, Zhang B, et al. The availability and safety study of remimazolam besylate for injection on sedation of ERAS Patients under mechanical ventilation in ICU: protocol for a randomized, open-label, controlled trial[J]. Front Med (Lausanne), 2021, 8: 735473., articleTitle=The availability and safety study of remimazolam besylate for injection on sedation of ERAS Patients under mechanical ventilation in ICU: protocol for a randomized, open-label, controlled trial, refAbstract=null), Reference(id=1194650238242755158, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2020, volume=80, issue=6, pageStart=625, pageEnd=633, url=null, language=null, rfNumber=[22], rfOrder=21, authorNames=Keam SJ, journalName=Drugs, refType=null, unstructuredReference=Keam SJ. Remimazolam: first approval[J]. Drugs, 2020, 80(6): 625-633., articleTitle=Remimazolam: first approval, refAbstract=null), Reference(id=1194650238322446935, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2023, volume=131, issue=5, pageStart=914, pageEnd=920, url=null, language=null, rfNumber=[23], rfOrder=22, authorNames=Gao YQ, Ihmsen H, Hu ZY, journalName=Br J Anaesth, refType=null, unstructuredReference=Gao YQ, Ihmsen H, Hu ZY, et al. Pharmacokinetics of remimazolam after intravenous infusion in anaesthetised children[J]. Br J Anaesth, 2023, 131(5): 914-920., articleTitle=Pharmacokinetics of remimazolam after intravenous infusion in anaesthetised children, refAbstract=null), Reference(id=1194650239383605848, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2022, volume=42, issue=2, pageStart=213, pageEnd=216, url=null, language=null, rfNumber=[24], rfOrder=23, authorNames=张彤彤, 邢飞, 李岩, journalName=中华麻醉学杂志, refType=null, unstructuredReference=张彤彤, 邢飞, 李岩, 等. 瑞马唑仑复合丙泊酚用于患儿门诊根管治疗术镇静的效果[J]. 中华麻醉学杂志, 2022, 42(2): 213-216., articleTitle=瑞马唑仑复合丙泊酚用于患儿门诊根管治疗术镇静的效果, refAbstract=null), Reference(id=1194650239446520409, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2021, volume=50, issue=23, pageStart=4062, pageEnd=4064, 4070, url=null, language=null, rfNumber=[25], rfOrder=24, authorNames=杨海扣, 孙剑, 王巧, journalName=重庆医学, refType=null, unstructuredReference=杨海扣, 孙剑, 王巧, 等. 瑞马唑仑和右美托咪定镇静在婴幼儿心脏超声检查中的应用比较[J]. 重庆医学, 2021, 50(23): 4062-4064, 4070., articleTitle=瑞马唑仑和右美托咪定镇静在婴幼儿心脏超声检查中的应用比较, refAbstract=null), Reference(id=1194650239513629274, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, doi=null, pmid=null, pmcid=null, year=2012, volume=115, issue=2, pageStart=274, pageEnd=283, url=null, language=null, rfNumber=[26], rfOrder=25, authorNames=Antonik LJ, Goldwater DR, Kilpatrick GJ, journalName=Anesth Analg, refType=null, unstructuredReference=Antonik LJ, Goldwater DR, Kilpatrick GJ, et al. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics[J]. Anesth Analg, 2012, 115(2): 274-283., articleTitle=A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics, refAbstract=null)], funds=[Fund(id=1194650236590199359, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, awardId=2022xkj087, language=EN, fundingSource=Anhui Medical University Funded Project(2022xkj087), fundOrder=null, country=null), Fund(id=1194650236644725312, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, awardId=2022xkj087, language=CN, fundingSource=安徽医科大学校基金资助项目(2022xkj087), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1194650232836297233, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, xref=null, ext=[AuthorCompanyExt(id=1194650232844685842, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China), AuthorCompanyExt(id=1194650232857268755, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, companyId=1194650232836297233, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=阜阳市人民医院麻醉科,安徽阜阳 236000)])], figs=[ArticleFig(id=1194650235944276535, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=EN, label=Fig.1, caption=Modified sequential diagram of remimazolam for preoperative sedation in pediatric patients, figureFileSmall=3vKlEZ0NSbOAJ6YGvIv+iA==, figureFileBig=GOn15npEJl5z6DiXSWa8Zw==, tableContent=null), ArticleFig(id=1194650236007191096, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=CN, label=图1, caption=瑞马唑仑用于患儿术前镇静的改良序贯图, figureFileSmall=3vKlEZ0NSbOAJ6YGvIv+iA==, figureFileBig=GOn15npEJl5z6DiXSWa8Zw==, tableContent=null), ArticleFig(id=1194650236086882873, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=EN, label=Tab.1, caption=

Comparison of general indicators between two groups of pediatric patients with remimazolam for preoperative sedation

, figureFileSmall=null, figureFileBig=null, tableContent=
指标

阳性组

(n=13)

阴性组

(n=10)

t/χ2/ZP
性别[例(%)]-1.000
11(84.6)8(80.0)
2(15.4)2(20.0)
年龄(岁, $\bar{x}±s$)3.3±1.53.5±1.0-0.3530.728
BMI(kg/m2, $\bar{x}±s$)19.25±2.9618.75±3.100.3900.700
手术时间(min, $\bar{x}±s$)29.23±14.4125.50±9.270.7110.485
PSAS评分[例(%)]-0.1790.858
3分7(53.8)5(50.0)
4分6(46.2)5(50.0)
), ArticleFig(id=1194650236174963258, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=CN, label=表1, caption=

两组瑞马唑仑术前镇静患儿基线指标比较

, figureFileSmall=null, figureFileBig=null, tableContent=
指标

阳性组

(n=13)

阴性组

(n=10)

t/χ2/ZP
性别[例(%)]-1.000
11(84.6)8(80.0)
2(15.4)2(20.0)
年龄(岁, $\bar{x}±s$)3.3±1.53.5±1.0-0.3530.728
BMI(kg/m2, $\bar{x}±s$)19.25±2.9618.75±3.100.3900.700
手术时间(min, $\bar{x}±s$)29.23±14.4125.50±9.270.7110.485
PSAS评分[例(%)]-0.1790.858
3分7(53.8)5(50.0)
4分6(46.2)5(50.0)
), ArticleFig(id=1194650236254655035, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=EN, label=Tab.2, caption=

Comparison of MAP, HR and SpO2 of pediatric patients before and after sedation with remimazolam ($\bar{x}±s$, n=23)

, figureFileSmall=null, figureFileBig=null, tableContent=
时间点MAP(mmHg)HR(次/min)SpO2(%)
镇静前69.48±7.03107.30±10.6898.00±0.91
镇静后68.39±7.30107.87±11.1597.65±0.98
t1.910-1.8421.886
P0.0690.0790.073
), ArticleFig(id=1194650236321763900, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=CN, label=表2, caption=

患儿瑞马唑仑镇静前后MAP、HR、SpO2对比($\bar{x}±s$,n=23)

, figureFileSmall=null, figureFileBig=null, tableContent=
时间点MAP(mmHg)HR(次/min)SpO2(%)
镇静前69.48±7.03107.30±10.6898.00±0.91
镇静后68.39±7.30107.87±11.1597.65±0.98
t1.910-1.8421.886
P0.0690.0790.073
), ArticleFig(id=1194650236384678461, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=EN, label=Tab.3, caption=

Comparison of sedation scores, PSAS scores, mask acceptance scores and anesthesia awakening time between two groups of patients with remimazolam for preoperative sedation

, figureFileSmall=null, figureFileBig=null, tableContent=
指标

阳性组

(n=13)

阴性组

(n=10)

Z/tP
镇静评分[例(%)]-1.8880.059
2分9(69.2)10(100.0)
3分4(30.8)0
PSAS评分[例(%)]-3.632<0.001
1分8(61.5)4(40.0)
2分5(38.5)6(60.0)
3分00
面罩接受程度评分[例(%)]-4.513<0.001
2分04(40.0)
3分06(60.0)
4分13(100.0)0
麻醉清醒时间(min, $\bar{x}±s$)21.15±8.0723.10±8.74-0.5530.586
), ArticleFig(id=1194650236447593022, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1194617493185601725, language=CN, label=表3, caption=

两组瑞马唑仑术前镇静评分、PSAS评分、麻醉诱导时面罩接受程度评分、麻醉清醒时间比较

, figureFileSmall=null, figureFileBig=null, tableContent=
指标

阳性组

(n=13)

阴性组

(n=10)

Z/tP
镇静评分[例(%)]-1.8880.059
2分9(69.2)10(100.0)
3分4(30.8)0
PSAS评分[例(%)]-3.632<0.001
1分8(61.5)4(40.0)
2分5(38.5)6(60.0)
3分00
面罩接受程度评分[例(%)]-4.513<0.001
2分04(40.0)
3分06(60.0)
4分13(100.0)0
麻醉清醒时间(min, $\bar{x}±s$)21.15±8.0723.10±8.74-0.5530.586
)], attaches=null, journal=Journal(id=1146441329971666965, delFlag=0, nameCn=解放军医学杂志, nameEn=Medical Journal of Chinese People’s Liberation Army, nameHistory1=null, nameHistory2=null, issn=0577-7402, eissn=null, cn=11-1056/R, coden=null, periodic=0, language=CN, oaType=是, ccby=CC BY-NC-ND, superviseOffice=null, ownerOffice=null, pubOffice=null, editorOffice=null, officeType=null, aims=null, clcCode=null, officeProv=null, officeCity=null, officeAddr=null, officeZip=null, officeEmail=null, officePhone=null, editDirector=null, officeDirector=null, officeDirectorPhone=null, officeStaffNum=null, officeEmpNum=null, coverPicUrl=6srot5PcoYX30Oa4xeTmeg==, journalPrice=null, startedYear=null, abbrevIsoEn=null, journalRemark=null, publicationField=null, createdTime=1751262512917, updatedTime=1761735725513, createdBy=18614031015, updatedBy=13701087609, firstLetterCn=M, firstLetterEn=M, subjectCode=Life Sciences, subjectName=Life Sciences, subjectCodeEn=Life Sciences, subjectNameEn=null, picCn=6srot5PcoYX30Oa4xeTmeg==, picEn=ELwBh5xqrSTlIs7HmSNt2Q==, jcr=null, cjcr=null, exts=[JournalExt(id=1190369167564968109, language=CN, name=解放军医学杂志, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1761735725537, updatedTime=1761735725537, createdBy=13701087609, updatedBy=13701087609, submissionGuidelinesUrl=, submissionAuthorUrl=#, submissionEditorUrl=#, submissionReviewUrl=#, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""}), JournalExt(id=1190369167615299758, language=EN, name=Medical Journal of Chinese People’s Liberation Army, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1761735725549, updatedTime=1761735725549, createdBy=13701087609, updatedBy=13701087609, submissionGuidelinesUrl=, submissionAuthorUrl=#, submissionEditorUrl=#, submissionReviewUrl=#, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""})], databaseList=null, tenantJournalId=1189873630562394117, websiteList=[Website(id=1189873845923287108, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1189873630562394117, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/jfjyxzz/CN, language=CN, createTime=1761617631655, createBy=18614031015, updateTime=1761622010471, updateBy=18614031015, name=解放军医学杂志-中文, tplId=1146099689490845704, title=解放军医学杂志, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1189924939378520839, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873845923287108, code=articleTextType, value=kx, createTime=1761629813284, updateTime=1761629813284, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924939353355012, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873845923287108, code=banner, value=null, createTime=1761629813278, updateTime=1761629813278, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924939399492362, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873845923287108, code=grayFlag, value=0, createTime=1761629813289, updateTime=1761629813289, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924939344966403, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873845923287108, code=logo, value=https://castjournals.cast.org.cn/joweb/jfjyxzz/CN/file/pic?fileId=+zXjYVhun8ZOAA6+aKx2hw==, createTime=1761629813276, updateTime=1761629813276, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924939412075276, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873845923287108, code=minRunFlag, value=0, createTime=1761629813292, updateTime=1761629813292, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924939374326534, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873845923287108, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/jfjyxzz/CN/file/pic, createTime=1761629813283, updateTime=1761629813283, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924939407880971, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873845923287108, code=silenceFlag, value=0, createTime=1761629813291, updateTime=1761629813291, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924939361743621, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873845923287108, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1761629813280, updateTime=1761629813280, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924939386909448, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873845923287108, code=themeColor, value=null, createTime=1761629813286, updateTime=1761629813286, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924939395298057, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873845923287108, code=themeStyle, value=null, createTime=1761629813288, updateTime=1761629813288, creator=18614031015, updator=18614031015)]), Website(id=1189873846057504839, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1189873630562394117, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/jfjyxzz/EN, language=EN, createTime=1761617631687, createBy=18614031015, updateTime=1761622030030, updateBy=18614031015, name=解放军医学杂志-英文, tplId=1146101810881728533, title=Medical Journal of Chinese People’s Liberation Army, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1189924968168223505, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873846057504839, code=articleTextType, value=kx, createTime=1761629820148, updateTime=1761629820148, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924968147251982, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873846057504839, code=banner, value=null, createTime=1761629820143, updateTime=1761629820143, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924968185000724, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873846057504839, code=grayFlag, value=0, createTime=1761629820152, updateTime=1761629820152, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924968138863373, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873846057504839, code=logo, value=https://castjournals.cast.org.cn/joweb/jfjyxzz/EN/file/pic?fileId=+zXjYVhun8ZOAA6+aKx2hw==, createTime=1761629820141, updateTime=1761629820141, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924968197583638, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873846057504839, code=minRunFlag, value=0, createTime=1761629820155, updateTime=1761629820155, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924968159834896, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873846057504839, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/jfjyxzz/EN/file/pic, createTime=1761629820146, updateTime=1761629820146, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924968193389333, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873846057504839, code=silenceFlag, value=0, createTime=1761629820154, updateTime=1761629820154, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924968155640591, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873846057504839, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1761629820145, updateTime=1761629820145, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924968172417810, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873846057504839, code=themeColor, value=null, createTime=1761629820149, updateTime=1761629820149, creator=18614031015, updator=18614031015), WebsiteProps(id=1189924968180806419, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1189873846057504839, code=themeStyle, value=null, createTime=1761629820151, updateTime=1761629820151, creator=18614031015, updator=18614031015)])], journalTitle=解放军医学杂志, weixinUrl=null, journalUrl=http://zh.jfjyxzz.org.cn/, iacademicId=null, status=1, seqNo=null, journalTitleEn=Medical Journal of Chinese People’s Liberation Army, journalPhotoCn=6srot5PcoYX30Oa4xeTmeg==, journalPhotoEn=ELwBh5xqrSTlIs7HmSNt2Q==, journalFirstLetter=M, journalRecommend=null, journalNew=null, journalCollection=null, jcrJf=null, cjcrJf=null, jcrJfStr=null, cjcrJfStr=null, submissionFirstDecision=null, sciSubjectClassification=null, casSubjectClassification=null, citeScore=null, totalCitationFrequency=null, icpCode=null, psCode=null, advertisingLicenseCode=null, copyrightInformation=null, country=null, option=, provinceCode=null, provinceName=null, collectFlag=false), detailUrlCn=https://castjournals.cast.org.cn/joweb/jfjyxzz/CN/10.11855/j.issn.0577-7402.1632.2024.0711, detailUrlEn=https://castjournals.cast.org.cn/joweb/jfjyxzz/EN/10.11855/j.issn.0577-7402.1632.2024.0711, pdfUrlCn=https://castjournals.cast.org.cn/joweb/jfjyxzz/CN/PDF/10.11855/j.issn.0577-7402.1632.2024.0711, pdfUrlEn=https://castjournals.cast.org.cn/joweb/jfjyxzz/EN/PDF/10.11855/j.issn.0577-7402.1632.2024.0711, aliStartDate=null, aliEndDate=null, collectionFlag=false, citedCount=null, citedUrl=null, reference=null)
收藏切换
瑞马唑仑对小儿术前镇静的半数有效剂量分析
收藏切换
PDF下载
吴美潮 , 杨芳芳 , 代晨旭 , 马行军 , 蔡宁 *
解放军医学杂志 | 临床研究 2025,50(2): 141-145
收起
收藏切换
解放军医学杂志 | 临床研究 2025, 50(2): 141-145
瑞马唑仑对小儿术前镇静的半数有效剂量分析
全屏
吴美潮, 杨芳芳, 代晨旭, 马行军, 蔡宁*
作者信息
  • 阜阳市人民医院麻醉科,安徽阜阳 236000
  • 吴美潮,硕士研究生,主治医师,主要从事小儿麻醉、骨科麻醉、区域阻滞麻醉等方面的临床研究

通讯作者:

蔡宁,E-mail:
Determination of median effective dose of remimazolam for preoperative sedation in pediatric patients
Mei-Chao Wu, Fang-Fang Yang, Chen-Xu Dai, Xing-Jun Ma, Ning Cai*
Affiliations
  • Department of Anesthesia, Fuyang People's Hospital, Fuyang, Anhui 236000, China
出版时间: 2025-02-28 doi: 10.11855/j.issn.0577-7402.1632.2024.0711
文章导航
收藏切换

目的 采用改良Dixon序贯法确定瑞马唑仑用于1~6岁患儿术前镇静的半数有效剂量(ED50)。方法 本研究为前瞻性临床研究。纳入2023年1-7月在阜阳市人民医院择期行全身麻醉下短小手术(手术时间≤1 h)的小儿患者。纳入标准为:年龄1~6岁,美国麻醉医师协会(ASA)健康状况分级Ⅰ-Ⅱ级,术前父母分离焦虑量表(PSAS)评分≥3分。术前静脉注射瑞马唑仑并对镇静效果进行评估,采用改良Dixon序贯法确定其ED50,首例初始剂量设置为0.10 mg/kg,剂量梯度设置为0.02 mg/kg,当患儿镇静评分≥2分、术前PSAS评分<3分且麻醉诱导时面罩接受程度评分为4分时认定镇静成功(阳性,纳入阳性组),后一例患儿在前一例患儿用药量的基础上减少0.02 mg/kg,当任何一个指标评分达不到设定标准时则认定镇静失败(阴性,纳入阴性组),后一例患儿在前一例患儿用药量基础上增加0.02 mg/kg,当连续有7个阳性、阴性拐点交替显现后结束研究。采用概率单位回归分析(Probit)法确定瑞马唑仑术前镇静剂量的ED50、ED95及95%可信区间(CI)。记录患儿手术结束后的麻醉苏醒时间及麻醉期间气道痉挛、呼吸抑制、低血压、恶心呕吐等不良反应的发生情况。结果 共纳入患儿23例,其中阳性组13例,阴性组10例。所有患儿镇静前后平均动脉压、心率、血氧饱和度比较差异均无统计学意义(P>0.05)。与阴性组比较,阳性组患儿术前父母分离焦虑程度降低,麻醉诱导时面罩接受程度增高,差异有统计学意义(P<0.05);两组镇静评分及麻醉清醒时间比较差异均无统计学意义(P>0.05)。瑞马唑仑用于1~6岁患儿术前镇静的ED50为0.051 mg/kg(95%CI 0.033~0.065 mg/kg),ED95为0.077 mg/kg(95%CI 0.064~0.161 mg/kg)。所有患儿麻醉期间均未出现气道痉挛、呼吸抑制、低血压、恶心呕吐等不良反应。结论 瑞马唑仑静脉注射用于1~6岁患儿术前镇静的ED50为0.051 mg/kg(95%CI 0.033~0.065 mg/kg),且具有良好的可控性及安全性。

瑞马唑仑  /  患儿  /  术前镇静  /  改良序贯法  /  剂量-效应关系

Objective To determine the median effective dose (ED50) of remimazolam for preoperative sedation in pediatric patients aged 1-6 years using the modified Dixon sequential method. Methods This is a prospective clinical study. Pediatric patients scheduled for elective short surgery (surgery time ≤1 h) under general anesthesia from January to July 2023 were selected. Inclusion criteria were age 1-6 years, an ASA physical status Ⅰ-Ⅱ and the preoperative parent separation anxiety scale (PSAS) score ≥3 points. Remimazolam was administered intravenously preoperatively, and its sedative effect was assessed. The modified Dixon sequential method was used to determine the ED50 of remimazolam, with the initial dose set at 0.10 mg/kg and the dose increment set at 0.02 mg/kg. Sedation was considered successful (positive, included in positive group) if the child with sedation score ≥2 points, preoperative PSAS score <3 points,and the mask acceptance score of 4 points during anesthesia induction. If any criterion was not met, sedation was considered failure (negative, included in negative group), and the next patient's dosage was increased by 0.02 mg/kg based on the previous patient's dosage. The test was completed after 7 consecutive positive and negative turning points appeared alternately. Probabilistic unit regression analysis was used to determine the ED50, ED95 and the corresponding 95% confidence interval (CI) of remimazolam for preoperative sedation. Postoperative recovery time and adverse events such as airway spasm, respiratory depression, hypotension, nausea and vomiting during anesthesia were recorded. Results A total of 23 pediatric patients were included, with 13 in positive group and 10 in negative group. There were no statistically significant differences in mean arterial pressure, pulse oxygen saturation or heart rate before and after sedation (P>0.05). Compared with negative group, positive group showed a significant reduction in preoperative parent separation anxiety and an increase in mask acceptance during anesthesia (P<0.05). There was no significant difference in sedation score and anesthesia awakening time between two groups (P>0.05). The ED50 of remimazolam for preoperative sedation in pediatric patients aged 1-6 years was 0.051 mg/kg (95%CI 0.033-0.065 mg/kg), and the ED95 was 0.077 mg/kg (95%CI 0.064-0.161 mg/kg). No adverse events such as airway spasm, respiratory depression, hypotension, nausea and vomiting occurred during anesthesia in any of pediatric patients. Conclusion The ED50 of intravenous administration of remimazolam for preoperative sedation in pediatric patients aged 1-6 years is 0.051 mg/kg (95%CI 0.033-0.065 mg/kg).

remimazolam  /  pediatric patient  /  preoperative sedation  /  modified sequential method  /  dose-effect relationship
吴美潮, 杨芳芳, 代晨旭, 马行军, 蔡宁. 瑞马唑仑对小儿术前镇静的半数有效剂量分析. 解放军医学杂志, 2025 , 50 (2) : 141 -145 . DOI: 10.11855/j.issn.0577-7402.1632.2024.0711
Mei-Chao Wu, Fang-Fang Yang, Chen-Xu Dai, Xing-Jun Ma, Ning Cai. Determination of median effective dose of remimazolam for preoperative sedation in pediatric patients[J]. Medical Journal of Chinese People’s Liberation Army, 2025 , 50 (2) : 141 -145 . DOI: 10.11855/j.issn.0577-7402.1632.2024.0711
小儿认知能力有限,对情感的调节能力较差,大多数需要手术的患儿与父母分离、进入陌生的手术室环境会出现哭闹、挣扎等焦虑及恐惧表现[1],而严重的术前焦虑情绪会增加患儿麻醉诱导及苏醒期不良反应和术后不良行为发生的风险[2-3]。因此,近年来术前镇静已逐渐成为小儿舒适化医疗的重要组成部分[4-5]。瑞马唑仑作为咪达唑仑的类似物,是一种新型镇静药物,起效快,半衰期短,停药后苏醒快速[6-7],已有研究将其用于儿童全麻及检查镇静[8-11],但目前用于小儿镇静的合适剂量尚未明确。本研究使用改良Dixon序贯法[12]确定患儿静脉注射瑞马唑仑用于术前镇静的半数有效剂量(median effective dose,ED50),旨在为小儿麻醉用药提供综合参考,以进一步改善患儿及家属的就医体验。
本研究为前瞻性临床干预性研究(临床试验注册号:ChiCTR2400093817)。选择阜阳市人民医院2023年1-7月择期在全身麻醉下行短小手术的小儿患者。纳入标准:年龄1~6岁;美国麻醉医师协会(American Society of Anesthesiologists,ASA)健康状况分级Ⅰ-Ⅱ级,术前父母分离焦虑量表(preoperative parent separation anxiety scale,PSAS)评分≥3分。排除标准:手术时间>1 h;术前无法在手术室外建立外周静脉通路;有神经系统疾病、精神疾病、心肺疾病病史;合并肝、肾功能异常;对本研究使用的药物过敏;术前24 h应用镇静或镇痛药物。剔除标准:患者或其监护人要求退出;术中出现手术意外;数据缺失或失访。本研究获阜阳市人民医院伦理委员会批准([2022]3号),术前所有患者家属均知情并签署知情同意书。
麻醉医师术前1 d至病房对患儿进行术前访视,并进行PSAS评分。患儿术前均未使用任何药物,并在病房提前建立外周静脉通路。术前镇静在手术等待区进行,并由家属陪同。麻醉医师通过静脉注射瑞马唑仑(宜昌人福药业有限责任公司,生产批号:20702031)对PSAS评分≥3分的患儿进行术前镇静,并由另一位麻醉医师进行效果评估,评估医师为接受过相关专业培训的固定医师,对患儿药物使用剂量不知情,以尽量减小不同医师评估造成的误差。使用便携式监护仪监测平均动脉压(mean arterial pressure,MAP)、血氧饱和度(pulse oxygen saturation,SpO2)及心率(heart rate,HR),携带简易呼吸器备用。给药后观察5 min,待药物完全起效后,将患儿转运至手术室,常规行心电图、血压、HR、SpO2监测,面罩吸氧,并在给药10 min内进行麻醉诱导时面罩接受程度评分。
采用改良Dixon序贯法进行研究。在预试验中,研究者设计了不同瑞马唑仑剂量组(分别为0.10、0.20和0.30 mg/kg)用于小儿术前镇静并观察每组有效率,以确定本研究的初始剂量,结果发现瑞马唑仑剂量在0.10 mg/kg时符合对ED50的最佳猜测。设定第1例患儿瑞马唑仑静脉注射剂量为0.10 mg/kg,相邻患儿给药剂量梯度为0.02 mg/kg。本研究采用镇静评分[13]、PSAS评分[14]及麻醉诱导时面罩接受程度评分[15]对患儿的镇静效果进行综合评估。当患儿镇静评分≥2分、PSAS评分<3分且麻醉诱导时面罩接受程度评分为4分时为镇静成功(阳性),则后一例在前一例用药剂量的基础上减少0.02 mg/kg,相反若任何一项评分达不到相应标准时则认定为镇静失败(阴性),后一例在前一例用药剂量的基础上增加0.02 mg/kg,当连续7个阳性、阴性拐点交替显现之后结束研究。本研究中所有镇静失败患儿均不使用其他药物进行镇静补救,以免对其他观察指标造成影响,如有患儿被剔除,则下一例被纳入患儿使用的药物剂量与被剔除者相同。将最终纳入的所有患儿分为两组,镇静成功者为阳性组,镇静失败者为阴性组。
静脉注射芬太尼3 μg/kg、丙泊酚2 mg/kg、顺阿曲库铵0.15 mg/kg进行全麻诱导,气管插管后进行机械控制通气,设置呼吸参数:潮气量8~10 ml/kg,呼吸频率14~20次/min,呼气末二氧化碳分压35~45 mmHg,吸呼比1:1.5,吸入氧气浓度60%。术中吸入七氟醚(1%~2%),静脉泵注瑞芬太尼[0.1~0.3 μg/(kg.min)]及丙泊酚[2~6 mg/(kg.h)]进行麻醉维持。手术过程中根据手术需要及麻醉深度调整维持药物的剂量,使脑电双频指数(bispectral index,BIS)维持在40~60。手术结束后停用所有麻醉药物,待达到拔管指征后将气管导管拔除。术中若出现低血压(血压降低超过基线水平的20%),则静脉注射麻黄碱0.1 mg/kg;若术后SpO2<90%,给予抬下颌或面罩加压吸氧处理。
(1)基线指标,包括体重指数(body mass index,BMI)、性别、年龄、手术时间、用药前PSAS评分等。(2)主要观察指标:给药后PSAS评分(1分,容易与父母分离;2分,呜咽易于安抚;3分,哭闹并不容易安抚;4分,哭闹且紧附于父母)。(3)次要观察指标:①给药后镇静评分(1分,流泪并挣扎;2分,警惕;3分,困倦、昏昏欲睡;4分,入睡);②麻醉诱导时面罩接受程度评分(1分,生气并反抗挣扎;2分,害怕且不容易安静;3分,害怕但容易安静;4分,不害怕并配合);③瑞马唑仑镇静前、镇静后3 min患儿血压、HR及SpO2;④麻醉清醒时间;⑤麻醉期间不良反应发生情况,包括气道痉挛、呼吸抑制、低血压、恶心呕吐等。
采用SPSS 22.0软件进行统计分析。符合正态分布的计量资料以$\bar{x}±s$表示,组间比较采用成组t检验,组内比较采用配对t检验;不符合正态分布的计量资料以M(Q1Q3)表示,组间比较采用Mann-Whitney U检验。计数资料以例(%)表示,组间比较采用Fisher确切概率法。等级资料组间比较采用秩和检验。采用概率单位回归(Probit)分析法确定瑞马唑仑用于1~6岁患儿术前镇静的ED50、ED95及其95%CI。P<0.05为差异有统计学意义。
最终纳入患儿23例,其中阳性组(镇静成功)13例,阴性组(镇静失败)10例,两组患儿基线指标比较差异均无统计学意义(P>0.05,表1)。
23例患儿镇静前后MAP、HR、SpO2比较差异均无统计学意义(P>0.05,表2)。
与阴性组比较,阳性组患儿术前父母分离焦虑程度降低,麻醉诱导时面罩接受程度增高,差异有统计学意义(P<0.05)。两组镇静评分及麻醉清醒时间比较差异均无统计学意义(P>0.05) (表3)。
瑞马唑仑用于1~6岁患儿术前镇静的ED50为0.051 mg/kg (95%CI 0.033~0.065 mg/kg),ED95为0.077 mg/kg (95%CI 0.064~0.161 mg/kg)(图1)。
所有患儿麻醉期间均未发生气道痉挛、呼吸抑制、低血压、恶心呕吐等不良反应。
据报道,75%需要手术的患儿会出现术前焦虑情绪,术前强制进行全麻诱导可能导致术毕一段时间内不良行为改变或成年后人格心理障碍的发生[3,16];因此,近年来术前镇静已成为小儿麻醉的关注重点。有研究表明,学龄前患儿对父母依赖性强,更容易发生术前焦虑[14],故本研究选取1~6岁的患儿作为术前镇静的研究对象。
当前,小儿术前镇静用药选择、用药途径多种多样。咪达唑仑口服及右美托咪定滴鼻小儿体验感好,接受度高,但起效缓慢[17-18]。艾司氯胺酮静脉注射起效迅速、作用显著、呼吸抑制轻,但存在一些缺陷如导致分泌物增多等[19]。因此,探索更适合儿童镇静的临床用药仍是当前研究的热点。瑞马唑仑作为一种新研发的水溶性苯二氮䓬类超短效镇静药物,是在咪达唑仑的结构基础上引进丙酸甲酯侧链而形成的,可作用于γ-氨基丁酸(GABA)⁃A受体,产生催眠及抗焦虑效果,代谢过程基本上不受肝肾功能的影响,代谢产物唑仑丙酸几乎不具有药理活性,减少了药物蓄积,并可被氟马西尼特效拮抗,同时起效快,半衰期短,停药后苏醒迅速,无注射痛,不良反应少,且镇静程度可操控性强[7,20-21];当前已有多个国家批准将其作为程序性镇静药物及静脉麻醉药物[22]。新近研究表明,瑞马唑仑在儿童体内的药代动力学与成人相似,其特点为清除率高、分布量小、半衰期短,是一种具有良好可控性的儿科麻醉药物[23];上述特点也符合小儿术前镇静用药的要求,但目前对其用于儿童患者的ED50未见相关报道,因此本研究对此进行了探索。
本研究使用改良Dixon序贯法测定患儿静脉注射瑞马唑仑用于术前镇静的ED50。该方法所需样本量少、操作简单且结果准确,是当前检测药物ED50的常用方法[12]。本研究结果显示,瑞马唑仑用于术前镇静的ED50为0.051 mg/kg(95%CI 0.033~0.065 mg/kg),ED95为0.077 mg/kg(95%CI 0.064~0.161 mg/kg)。与张彤彤等[24]的研究中瑞马唑仑用于儿童门诊检查的用药剂量为0.2 mg/kg,以及杨海扣等[25]在婴幼儿超声心动图检查中使用的剂量0.3 mg/kg相比,本研究结果的剂量较低,分析原因可能为以上研究为侵入性检查或有创操作,刺激较大,需要更深程度的镇静,而本研究仅观察患儿与父母的分离焦虑评分等,基本上无操作刺激,所需镇静程度较低。
研究证实,在瑞马唑仑剂量为0.01~0.35 mg/kg时,生命体征一直维持平稳,无低血压或高血压发生[26]。瑞马唑仑用于6岁以下儿童时,其药代动力学与成人相似[23]。本研究中使用瑞马唑仑的剂量范围为0.02~0.10 mg/kg,在安全性观察指标中,患儿给药前后的MAP、HR、SpO2对比差异无统计学意义,所有患儿均苏醒迅速,未发生气道痉挛、呼吸抑制、低血压、恶心呕吐等不良反应,提示瑞马唑仑用于小儿术前镇静对呼吸循环的抑制轻微,不影响术后麻醉苏醒,安全性及可控性强。
本研究仍存在不足之处:(1)仅纳入1~6岁患儿,对此年龄段未进行更细致的分层研究,对于1~3岁与4~6岁年龄段患儿使用瑞马唑仑的ED50,以及<1岁、>6岁年龄段患儿的术前镇静效果尚需进一步探索;(2)所选手术均为短小手术,患儿出院快,未对术后远期不良反应进行随访。
综上所述,本研究结果显示,瑞马唑仑用于1~6岁患儿术前镇静的ED50为0.051 mg/kg(95%CI 0.033~0.065 mg/kg),且具有良好的可控性及安全性。
  • 安徽医科大学校基金资助项目(2022xkj087)
参考文献 引证文献
排序方式:
[1]
王月, 初丽艳, 王珊珊, 等. 术前动画视频陪伴改善学龄前儿童分离焦虑及诱导配合的临床观察[J]. 中华医学杂志, 2021, 101(26): 2066-2070.
[2]
Ryu JH, Park SJ, Park JW, et al. Randomized clinical trial of immerse vevirtual reality tour of the operating theatre in children before anaesthesia[J]. Br J Surg, 2017, 104(12): 1628-1633.
[3]
Chow CHT, Van Ieshout RJ, Schmidt LA, et al. Systematic review: audiovisual interventions for reducing preoperative anxiety in children undergoing elective surgery[J]. J Pediatr Psychol, 2015, 41(2): 182-203.
[4]
Li B, Hou H, Bai J, et al. Paediatric preoperative sedation practices in tertiary maternity and children' shospitals in China: a questionnaire survey[J]. BMC Pediatr, 2021, 21(1): 336.
[5]
Van Den Bosch OFC, Alvarez-Jimenez R, Schet SG, et al. Breathing variability during propofol/remifentanil procedural sedation with a single additional dose of midazolam or s-ketamine: a prospective observational study[J]. J Clin Monit Comput, 2021, 36(4): 1219-1225.
[6]
李森, 蓝金辛, 杨铎, 等. 瑞马唑仑对重要器官的保护作用[J]. 解放军医学杂志, 2024, 49(10): 1105-1109.
[7]
Zhou J, Leonowens C, Ivaturi VD, et al. Population pharmaco-kinetic/pharmacodynarnic modeling for remimazolam in the induction and maintenance of general anesthesia in healthy subjects and in surgical subjects[J]. J Clin Anesth, 2020, 66: 109899.
[8]
Fang YB, Wang CY, Gao YQ, et al. The safety and efficacy of remimazolam tosylate for induction and maintenance of general anesthesia in pediatric patients undergoing elective surgery: study protocol for a multicenter, randomized, single-blind, positive-controlled clinical trial[J]. Front Pharmacol, 2023, 14: 1090608.
[9]
Kamata K, Asagi S, Shimoda Y, et al. Successful recording of direct cortical motor-evoked potential from a pediatric patient under remimazolam anesthesia: a case report[J]. JA Clinical Reports, 2022, 8(1): 66.
[10]
Horikoshi Y, Kuratani N, Tateno K, et al. Anesthetic management with remimazolam for a pediatric patient with Duchenne muscular dystrophy[J]. Medicine (Baltimore), 2021, 100 (49): e28209.
[11]
Shioji N, Everett T, Suzuki Y, et al. Pediatric sedation using dexmedetomidine and remimazolam for magnetic resonance imaging[J]. J Anesth, 2021, 36 (1): 1-4.
[12]
王仁安. 医学实验设计与统计分析[M]. 北京: 北京医科大学出版社, 2000: 114-136.
[13]
Malde AD, Pagedar RA, Jagtap SR. Oral clonidine in children: efficacy as premedicant and postoperative analgesic as compared to diazepam[J]. Indian J Anaesth, 2006, 50: 27-31.
[14]
张贝贝, 杨倚天, 贾佳, 等. 艾司氯胺酮用于不同年龄段患儿术前镇静的半数有效剂量[J]. 中华麻醉学杂志, 2022, 42(3): 320-322.
[15]
王小玲, 袁静静, 邢飞, 等. 小剂量艾司氯胺酮对患儿扁桃体腺样体切除术全麻苏醒期躁动的影响[J]. 临床麻醉学杂志, 2022, 38(2): 154-158.
[16]
Fortier MA, Del Rosario AM, Martin SR, et al. Perioperative anxiety in children[J]. Pediatr Anesth, 2010, 20(4): 318-322.
[17]
Bian Y, Zhou S, Hou H, et al. The optimal dose of oral midazolam with or without intranasal S-ketamine for premedication in children: a randomised, double blinded, sequential dose-finding trial[J]. Transl Pediatr, 2021, 10(11): 2941-2951.
[18]
Bromfalk Å, Myrberg T, Walldén J, et al. Preoperative anxiety in preschool children: a randomized clinical trial comparing midazolam, clonidine, and dexmedetomidine[J]. Pediatr Anesth, 2021, 31(11): 1225-1233.
[19]
Mihaljevic S, Pavlovic M, Reiner K, et al. Therapeutic mechanisms of ketamine[J]. Psychiatr Danub, 2020, 32(3-4): 325-333.
[20]
Guan XH, Jiao Z, Gong XF, et al. Efficacy of pretreatment with remimazolam on prevention of propofol-induced injection pain in patients undergoing abortion or curettage: a prospective, double-blinded, randomized and placebo-controlled clinicaltrial[J]. Drug Des Devel Ther, 2021, 15: 4551-4558.
[21]
Liu SJ, Su LX, Zhang B, et al. The availability and safety study of remimazolam besylate for injection on sedation of ERAS Patients under mechanical ventilation in ICU: protocol for a randomized, open-label, controlled trial[J]. Front Med (Lausanne), 2021, 8: 735473.
[22]
Keam SJ. Remimazolam: first approval[J]. Drugs, 2020, 80(6): 625-633.
[23]
Gao YQ, Ihmsen H, Hu ZY, et al. Pharmacokinetics of remimazolam after intravenous infusion in anaesthetised children[J]. Br J Anaesth, 2023, 131(5): 914-920.
[24]
张彤彤, 邢飞, 李岩, 等. 瑞马唑仑复合丙泊酚用于患儿门诊根管治疗术镇静的效果[J]. 中华麻醉学杂志, 2022, 42(2): 213-216.
[25]
杨海扣, 孙剑, 王巧, 等. 瑞马唑仑和右美托咪定镇静在婴幼儿心脏超声检查中的应用比较[J]. 重庆医学, 2021, 50(23): 4062-4064, 4070.
[26]
Antonik LJ, Goldwater DR, Kilpatrick GJ, et al. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics[J]. Anesth Analg, 2012, 115(2): 274-283.
2025年第50卷第2期
PDF下载
203
90
引用本文
BibTeX
文章信息
doi: 10.11855/j.issn.0577-7402.1632.2024.0711
  • 接收时间:2023-12-10
  • 首发时间:2025-11-10
  • 出版时间:2025-02-28
补充材料
相关文章
文章信息
作者
出版历史
  • 收稿日期:2023-12-10
  • 录用日期:2024-01-08
基金
Anhui Medical University Funded Project(2022xkj087)
安徽医科大学校基金资助项目(2022xkj087)
作者信息
    阜阳市人民医院麻醉科,安徽阜阳 236000

通讯作者:

蔡宁,E-mail:
参考文献
分享链接
https://castjournals.cast.org.cn/joweb/jfjyxzz/CN/10.11855/j.issn.0577-7402.1632.2024.0711
分享至
全文二维码

扫描看全文

引用本文
BibTeX
本文的引用情况
2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏