摘要
目的 确定瑞马唑仑用于不同年龄患儿术前镇静的半数有效剂量(ED50).方法 本研究为前瞻性研究.选取本院2023年7月至12月拟行择期手术患儿,年龄1～6岁,ASA分级Ⅰ或Ⅱ级,使用非药物干预后术前焦虑仍不缓解[亲子分离焦虑评分(PSAS)≥3分].根据年龄将患儿分为1～＜2岁组、2～＜3岁组、3～＜4岁组、4～＜5岁组和5～6岁组.与家长分离时患儿PSAS 1分为镇静效果满意,PSAS评分≥2分为镇静效果不满意.首例患儿瑞马唑仑剂量为0.3 mg/kg,剂量比1.15.若患儿镇静效果满意,下一例患儿瑞马唑仑剂量下降1个梯度;若患儿镇静效果不满意,下一例患儿瑞马唑仑剂量上升1个梯度.当出现7个交替波形时结束试验.采用Dixon-Massey方法计算ED50及其95％置信区间(CI).结果 1～＜2岁组、2～＜3岁组、3～＜4岁组、4～＜5岁组和5～6岁组分别纳入26、23、21、27、23 例患儿,瑞马唑仑术前镇静的 ED50(95％CI)分别为 0.152(0.126～0.178)、0.159(0.135～0.183)、0.171(0.147～0.196)、0.150(0.126～0.174)、0.146(0.121～0.170)mg/kg,组间比较差异无统计学意义(P＞0.05).结论 1～6岁患儿中每隔1岁,瑞马唑仑术前镇静ED50分别为0.152、0.159、0.171、0.150、0.146 mg/kg,且年龄因素并不影响该年龄段患儿瑞马唑仑术前镇静效应.
Abstract
Objective To determine the median effective dose(ED50)of remimazolam for preoper-ative sedation in pediatric patients of different ages.Methods This was a prospective study.American So-ciety of Anesthesiologists Physical Status classification Ⅰ or Ⅱ pediatric patients,aged 1-6 yr,scheduled for elective surgery in our hospital from July to December 2023,in whom the preoperative anxiety was still not relieved after non-drug intervention(preoperative separation anxiety score[PSAS]≥3),were selected.According to the age,the children were divided into 1-＜2 yr group,2-＜3 yr group,3-＜4 yr group,4-＜5 yr group and 5-6 yr group.A child's PSAS score=1 at the time of separation from parents was classified as satisfactory sedation,and a PSAS score ≥ 2 was classified as unsatisfactory sedation.The initial dose of remimazolam in each group was 0.3 mg/kg,dose ratio 1.15.If the child was satisfactorily sedated,the next patient received a lower dose of remimazolam,or conversely if the child was not satisfactorily sedated,a higher dose was given in the next patient.The test was ended when 7 alternating waveforms appeared.The Dixon-Massey method was used to calculate the ED50 and 95％ confidence interval.Results In 1-＜2 yr group,2-＜3 yr group,3-＜4 yr group,4-＜5 yr group and 5-6 yr group,a total of 120 children were in-cluded in this study,with 26,23,21,27 and 23 cases,respectively,and the ED50(95％ confidence in-terval)of remimazolam for preoperative sedation was 0.152(0.126-0.178),0.159(0.135-0.183),0.171(0.147-0.196),0.150(0.126-0.174),and 0.146(0.121-0.170)mg/kg,respectively.There was no sig-nificant difference between the groups(P＞0.05).Conclusions The ED50 of remimazolam for preoperative sedation is 0.152,0.159,0.171,0.150 and 0.146 mg/kg for every 1 yr in children aged 1-6 yr,and the age factor does not affect the preoperative sedative effect of remimazolam in children of this age group.
基金项目
广州市卫生健康科技一般引导项目(20181A010021)
万方数据