序贯法测定瑞马唑仑复合舒芬太尼用于无痛胃镜检查的有效剂量及不良反应分析

Analysis of the effective dose and adverse effects of remimazolam combined with sufentanil for painless gastroscopy determined by the sequential method

目的序贯法测定瑞马唑仑复合舒芬太尼在无痛胃镜检查的半数有效剂量(ED50)和95%有效剂量(ED95),观察其临床镇静效果以及不良反应。方法选取2021年3-10月山东第一医科大学第二附属医院行无痛胃镜检查的患者47例,美国麻醉医师协会(ASA)Ⅰ~Ⅱ级,根据世界卫生组织对年龄的划分,第1组年龄18~44岁(n=27),第2组45~60岁(n=20)。所有患者缓慢静脉注射0.1 g/kg舒芬太尼后,随后注入瑞马唑仑。瑞马唑仑的起始剂量为0.2 mg/kg,采用序贯法进行试验,剂量间差值为0.03 mg/kg,观察并记录不同时间点的改良警觉/镇静(MOAA/S)评分、检查时间、苏醒时间以及不良反应的情况。结果第1组苏醒时间明显短于第2组,差异有统计学意义(P<0.05);两组不良反应发生率比较,差异无统计学意义(P>0.05)。第1组瑞马唑仑起始剂量的ED50为0.188 mg/kg(95%CI:0.141~0.243 mg/kg),ED95为0.227 mg/kg(95%CI:0.131~0.253 mg/kg);第2组瑞马唑仑起始剂量的ED50为0.185 mg/kg(95%CI:0.153~0.235 mg/kg),ED95为0.218 mg/kg(95%CI:0.145~0.243 mg/kg)。结论瑞马唑仑复合舒芬太尼在无痛胃镜检查镇静时第1组起始剂量的ED50为0.188 mg/kg,ED95为0.227 mg/kg;第2组起始剂量的ED50为0.185 mg/kg,ED95为0.218 mg/kg,镇静效果佳,无明显不良反应。

Objective To determine the 50%effective dose(ED50)and 95%effective dose(ED95)of remimazolam combined with sufentanil in painless gastroscopy by the sequential method for observing its clinical sedative effect and adverse effects.Methods A total of 47 patients undergoing painless gastroscopy,with American Society of Anesthesiologists(ASA)gradeⅠ-Ⅱ,from March to October 2021 were included.According to the World Health Organization’s age classification,the first group was 18 to 44 years old(n=27)and the second group was 45 to 60 years old(n=20).All patients received a slow intravenous injection of 0.1 g/kg sufentanil followed by remimazolam.The starting dose of remimazolam was 0.2 mg/kg and the trial was conducted using the sequential method with an inter-dose difference of 0.03 mg/kg.Modified observer’s assessment of alert(MOAA/S)scores,time to examination,time to awakening and adverse reactions were observed and recorded at different time points.Results The awakening time differed between the two groups,with a statistically significant difference(P<0.05).In contrast,the adverse reactions were different between the two groups,with no statistical significance(P>0.05).For the first group,the ED50 for the starting dose of remimazolam was 0.188 mg/kg(95%CI:0.141-0.243 mg/kg)and the ED95 was 0.227 mg/kg(95%CI:0.131-0.253 mg/kg).In contrast,the ED50 for the starting dose of remimazolam in the second group was 0.185 mg/kg(95%CI:0.153-0.235 mg/kg)and the ED95 was 0.218 mg/kg(95%CI:0.145-0.243 mg/kg).Conclusion The ED50 and ED95 of remimazolam combined with sufentanil in the first group are 0.188 mg/kg and 0.227 mg/kg respectively for sedation during painless gastroscopy.In parallel,the ED50 and ED95 of the s tarting dose of the second group are 0.185 mg/kg and 0.218 mg/kg respectively.The sedative effe ct is good with no significant adverse effects.