雷马唑仑用于左至右分流先天性心脏病患儿的成功镇静:一项上下顺序分配试验。

IF 6.8 2区 医学 Q1 ANESTHESIOLOGY
European Journal of Anaesthesiology Pub Date : 2025-08-01 Epub Date: 2025-04-04 DOI:10.1097/EJA.0000000000002183
Ming Jin, Hongqi Lin, Lin Qiu, Hongdang Xu, Haoran Zhang, Shuhui Hou
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引用次数: 0

摘要

背景:本研究的结果为左向右分流先天性心脏病(CHD)患儿使用雷马唑仑镇静提供了见解。目的:探讨雷马唑仑对冠心病患儿成功镇静的中位有效剂量(ED50)和95%有效剂量(ED95)。设计:一项基于Dixon序贯法的非随机、非盲法研究。研究地点:河南省郑州市三级医院,研究日期:2023年10月20日至2024年5月18日。患者:78例患者成功完成研究,其中男性32例,女性45例。选择标准如下:1 ~ 6岁左右左右分流型冠心病患儿;ASA物理状态II-III。主要排除标准为:有镇静药物过敏史;术前使用研究药物以外的镇静药物;术前严重肝肾功能障碍;术前心动过缓;还有严重的术前呼吸系统疾病干预:观察患者静脉注射不同剂量的雷马唑仑后5min的镇静情况。主要观察指标:雷马唑仑对冠心病患儿镇静效果的ED50和ED95。结果:雷马唑仑对婴幼儿和学龄前CHD患儿镇静成功的ED50 (95% CI)分别为0.209 (0.184 ~ 0.234)mg kg-1、0.259 (0.234 ~ 0.284)mg kg-1和0.266 (0.207 ~ 0.325)mg kg-1。ED95 (95% CI)分别为0.356 (0.282 ~ 0.672)mg kg-1、0.404 (0.330 ~ 0.741)mg kg-1和0.408 (0.334 ~ 0.752)mg kg-1。静脉注射雷马唑仑未见严重不良反应。结论:本研究探讨了雷马唑仑在左-右分流型冠心病患儿术前镇静作用中的ED50和ED95。为左向右分流型冠心病患儿术前镇静用药提供指导。试验注册:https://www.chictr.org.cn/,标识符:ChiCTR2300076458。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Remimazolam for successful sedation in children with left-to-right shunt congenital heart disease: An up-and-down sequential allocation trial.

Remimazolam for successful sedation in children with left-to-right shunt congenital heart disease: An up-and-down sequential allocation trial.

Remimazolam for successful sedation in children with left-to-right shunt congenital heart disease: An up-and-down sequential allocation trial.

Remimazolam for successful sedation in children with left-to-right shunt congenital heart disease: An up-and-down sequential allocation trial.

Background: The findings of this study offer insights into the utilisation of remimazolam for sedation in paediatric patients with left-to-right shunt congenital heart disease (CHD).

Objective: To study the median effective dose (ED 50 ) and 95 percentile of the effective dose (ED 95 ) of remimazolam for successful sedation in children with CHD.

Design: A nonrandomised, nonblinded study based on the Dixon sequential method.

Setting: Tertiary hospitals in Zhengzhou, Henan Province, study dates: 20 October 2023 to 18 May 2024.

Patients: A total of 78 patients, comprising 32 males and 45 females, successfully completed the study. They were selected based on the following criteria: children aged 1 to 6 years with left-to-right shunt CHD; ASA physical status II-III. The key exclusion criteria were: history of allergy to sedative drugs; administration of sedative medications other than the study drug before surgery; severe pre-operative liver or kidney dysfunction; pre-operative bradycardia; and severe pre-operative respiratory diseases.

Intervention: The sedation status of the patients was observed for 5 min after intravenous administration of different doses of remimazolam.

Main outcome measures: The ED 50 and ED 95 of remimazolam for successful sedation in children with CHD.

Results: The ED 50 (95% CI) of remimazolam for successful sedation in infants, toddlers and preschool children with CHD were 0.209 (0.184 to 0.234) mg kg -1 , 0.259 (0.234 to 0.284) mg kg -1 and 0.266 (0.207 to 0.325) mg kg -1 , respectively. ED 95 (95% CI) were 0.356 (0.282 to 0.672) mg kg -1 , 0.404 (0.330 to 0.741) mg kg -1 and 0.408 (0.334 to 0.752) mg kg -1 , respectively. No serious adverse reactions were observed with intravenous remimazolam.

Conclusion: This study explored the ED 50 and ED 95 of remimazolam for pre-operative sedation in children with left-to-right shunt CHD. It provides guidance for pre-operative sedation medication in children with left-to-right shunt CHD.

Trial registration: https://www.chictr.org.cn/Identifier: ChiCTR2300076458.

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来源期刊
CiteScore
6.90
自引率
11.10%
发文量
351
审稿时长
6-12 weeks
期刊介绍: The European Journal of Anaesthesiology (EJA) publishes original work of high scientific quality in the field of anaesthesiology, pain, emergency medicine and intensive care. Preference is given to experimental work or clinical observation in man, and to laboratory work of clinical relevance. The journal also publishes commissioned reviews by an authority, editorials, invited commentaries, special articles, pro and con debates, and short reports (correspondences, case reports, short reports of clinical studies).
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