瑞马唑仑复合阿芬太尼用于无痛胃镜检查的半数有效量

Median effective dose of remimazolam combined with alfentanil for painless gastroscopy

目的测定瑞马唑仑复合阿芬太尼用于无痛胃镜检查的ED_(50)及95%有效量(95%effective dose,ED_(95)).方法选择行胃镜检查的患者60例,按年龄分为青年组(Y组,年龄18~44岁)和中年组(M组,年龄45~60岁),每组30例.所有患者静脉推注阿芬太尼5μg/kg,30 s后推注瑞马唑仑,初始剂量为0.1 mg/kg,改良警觉/镇静评分(modified Observer's Assess-ment of Alertness/Sedation,mOAA/S)<3分时进行胃镜检查.按照改良序贯法进行试验,根据胃镜检查的镇静效果,确定下一位患者的瑞马唑仑剂量.患者镇静"成功",则下一例患者瑞马唑仑剂量降低0.03 mg/kg,否则增加0.03 mg/kg.记录患者瑞马唑仑用量、胃镜检查时间、苏醒时间、术中知晓及不良反应发生情况,采用概率单位回归法计算瑞马唑仑的ED_(50)、ED_(95)及其95%CI.结果Y组的ED_(50)为0.13(0.11~0.16)mg/kg,ED_(95)为0.19(0.16~0.33)mg/kg;M组的ED_(50)为0.09(0.07~0.12)mg/kg,ED_(95)为0.18(0.13~0.57)mg/kg.M组与Y组的等效比值为0.68(0.22~0.98).两组患者检查时间、苏醒时间、低血压及呼吸抑制发生率比较,差异无统计学意义(P>0.05),Y组瑞马唑仑用量高于M组(P<0.05).无患者存在术中知晓.结论复合阿芬太尼5μg/kg时,瑞马唑仑用于青年患者无痛胃镜检查的ED_(50)为0.13(0.11~0.16)mg/kg,用于中年患者的ED_(50)为0.09(0.07~0.12)mg/kg,两者对应的等效比值为0.68(0.22~0.98).

Objective To determine the median effective dose(ED_(50))and 95%effective dose(ED_(95))of remimazolam combined with alfentanil for painless gastroscopy.MethodsA total of 60 patients who underwent gastroscopy were enrolled.According to their ages,they were divided into two groups(n=30):a young group(group Y,18-44 years old)and a middle-aged group(group M,45-60 years old).All patients were intravenously infused with 5μg/kg alfentanil,fllowed by a bolus injection of remimazolam 30 s later,with an initial dose of 0.1 mg/kg.When the modified Observer's Assessment of Alertness/Sedation Scale(mOAA/S)was less than 3 points,gastroscopy was performed.The current study was carried out using the up and down method,where the dose of remimazolam used by the next patient was determined based on the sedative effect of gastroscopy.If the patient"successfully"sedated,the remimazolam dose used by the next patient decreased by 0.03 mg/kg,otherwise increased by 0.03 mg/kg.The dose of remimazolam,gastroscopy time,recovery time,intraoperative awareness and adverse reactions were recorded.The ED_(50) and EDes of remimazolam and their 95%confidence interval(CI)were calculated by the probit regression method.Results The ED_(50) of remimazolam was 0.13(0.11,0.16)mg/kg and the EDes was 0.19(0.16,0.33)mg/kg in the group Y.The ED_(50) of remimazolam was 0.09(0.07,0.12)mg/kg and the ED_(95) was 0.18(0.13,0.57)mg/kg in the group M.The equivalent ratio of the group M versus the group Y was 0.68(0.22,0.98),There were no statistical differences in examination time,recovery time,the incidence of hypotension and respiratory depression between the two groups(P>0.05),and the dose of remimazolam in group Y was higher than that in group M(P<0.05).None of the patients had intraoperative awareness Conclusions When remimazolam is used in combination with 5μg/kg alfentanil,the ED_(50) of remimazolam for painless gastroscopy is 0.13(0.11,0.16)mg/kg for young patients and 0.09(0.07,0.12)mg/kg for middle-aged patients.The equivalent ratio of the two groups is 0.68(0.22,0.98).