Yu Eryou,Ding Wenkang,Xiang Zhen,et al.Observation of effective dose of remimazolam tosilate plus alfentanil for deep sedation in school-aged children[J].Journal of Clinical Pediatric Surgery,2025,(11):1061-1064.[doi:10.3760/cma.j.cn101785-202412027-013]
甲苯磺酸瑞马唑仑复合阿芬太尼用于学龄期儿童深度镇静的有效剂量观察
- Title:
- Observation of effective dose of remimazolam tosilate plus alfentanil for deep sedation in school-aged children
- 摘要:
- 目的 探索甲苯磺酸瑞马唑仑复合阿芬太尼用于学龄期儿童深度镇静的有效剂量。方法 本研究为前瞻性研究,选择2024年8月至2024年10月在湖南省儿童医院舒适化医疗中心接受无痛纤支镜诊疗的22例学龄期儿童作为研究对象。年龄6~12岁,美国麻醉医师协会(American Society of Anesthesiologists,ASA)分级Ⅰ~Ⅱ级。入室后患儿取仰卧位,先予静脉推注2 mL生理盐水,确认静脉通路顺畅且无注射痛,再缓慢静脉推注甲苯磺酸瑞马唑仑镇静,后予阿芬太尼10 ug/kg镇痛,给药完成后2 min内行改良警觉/镇静(Modified Observer’s Assessment of Alertness/Sedation Scale,MOAA/S)评分。甲苯磺酸瑞马唑仑初始剂量为0.2 mg/kg(剂量梯度0.05 mg/kg)。按Dixon改良序贯试验法,记录不同梯度剂量下患儿的镇静效果反应。通过概率单位Probit回归的方法计算甲苯磺酸瑞马唑仑镇静半数有效剂量(median effective dose,ED50)、95%有效剂量(95% effective dose,ED95)及其95%置信区间(confidence interval,CI)。结果 甲苯磺酸瑞马唑仑复合阿芬太尼用于学龄期儿童深度镇静(MOAA/S评分≤1分)的ED50、ED95及其95%CI分别为0.453(0.357~0.666)mg/kg和0.627(0.526~2.243)mg/kg。结论 本研究初步证实,甲苯磺酸瑞马唑仑复合阿芬太尼用于学龄期儿童深度镇静(MOAA/S评分≤1分)的ED50、ED95分别为0.453 mg/kg和0.627 mg/kg。
- Abstract:
- Objective To explore the effective dose of remimazolam tosilate plus alfentanil for deep sedation in school-age children. Methods From August 2024 to October 2024,24 school-age children aged 6-12 year (ASA grade Ⅰ-Ⅱ) were scheduled for painless bronchoscopy.Each child was placed in a supine position and injected intravenously with 2 ml of normal saline.It was utilized for confirming the patency of venous access without pain during injection.Remimazolam tosilate was slowly injected intravenously for sedation and followed by analgesia with alfentanil 10 ug/kg.And MOAA/S (Modified Observer’s Assessment of Alertness/Sedation Scale) score was performed within 2 min post-injection.The initial dose of remimazolam tosilate was 0.2 mg/kg with a dose gradient of 0.05 mg/kg.According to Dixon modified sequential test,sedation effect was recorded under different gradient doses.The values of median effective dose (ED50),95% effective dose (ED95) and their 95%CI were calculated with Probit regression. Results ED50,ED95 and their 95%CI for deep sedation (MOAA/S score ≤1) in school-age children using remimazolam tosilate plus alfentanil were 0.453(0.357-0.666) mg/kg and 0.627(0.526-2.243) mg/kg,respectively. Conclusions This study has preliminarily confirmed that ED50 and ED95 for deep sedation (MOAA/S score ≤1) in school-age children using remimazolam tosilate combined with alfentanil were 0.453 mg/kg and 0.627 mg/kg.
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备注/Memo
收稿日期:2024-12-10。
基金项目:广东省颐养健康慈善基金会(20240358)
通讯作者:杜真,Email:meggyzhen@163.com