口服咪达唑仑复合经鼻艾司氯胺酮用于小儿术前镇静的ED 90及临床效果  

The 90%effective dose and clinical effectiveness of oral midazolam combined with intranasal esmketamine for preoperative sedation in children

作　　者：周思易 徐韬[2] 卞勇[1] 侯慧艳 郑吉建 Zhou Siyi;Xu Tao;Bian Yong;Hou Huiyan;Zheng Jijian(Department of Anesthesiology,Shanghai Children's Medical Center,Shanghai Jiao Tong University School of Medicine,Shanghai 200127,China;Department of Anesthesiology,the International Peace Maternity and Child Health Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200030,China)

机构地区：[1]上海交通大学医学院附属上海儿童医学中心麻醉科,上海200127 [2]上海交通大学医学院附属国际和平妇幼保健院麻醉科,上海200030

出　　处：《国际麻醉学与复苏杂志》2022年第6期596-600,共5页International Journal of Anesthesiology and Resuscitation

基　　金：上海市科学技术委员会基金(20DZ2306700)。

摘　　要：目的:确定口服咪达唑仑联合经鼻艾司氯胺酮行小儿术前镇静时所需咪达唑仑的90%有效剂量(90% effective dose, ED 90),并观察其可行性。 方法:根据偏倚钱币序贯法依次对40例择期手术患儿进行前瞻性双盲序贯研究。主要观察指标为复合经鼻小剂量艾司氯胺酮30 min后使患儿达到亲子分离焦虑评分(Parental Separation Anxiety Score, PSAS)=1分的口服咪达唑仑剂量。次要观察指标为麻醉诱导前后的SBP和心率、镇静水平、起效时间、术前用药副作用、用药30 min时PSAS评分、面罩接受量表(Mask Acceptance Scale, MAS)评分、静脉穿刺反应(reaction to intravenous cannulation scale, ICS)评分、术后拔管时间、意识恢复时间、PACU停留时间、额外镇痛药物使用情况,以及低氧血症、恶心和呕吐的发生情况。用Isotonic回归分析法计算咪达唑仑ED 90及其95%CI。 结果:咪达唑仑口服复合0.25 mg/kg艾司氯胺酮滴鼻用于小儿术前镇静的ED 90为0.253 (95%CI 0.242~0.278)mg/kg,平均起效时间为(8.9±3.8)min。给药后患儿出现幻觉、兴奋、行为改变的发生率为7.5%,无患儿出现低氧血症、低血压、心动过缓、高血压、心动过速、恶心、呕吐等不良反应。 结论:0.25 mg/kg艾司氯胺酮滴鼻复合咪达唑仑口服能有效缓解小儿术前焦虑,咪达唑仑ED 90为0.253 mg/kg。Objective To determine the 90%effective dose(ED90)of oral midazolam combined with intranasal esketamine for preoperative sedation in children and observe its feasibility.Methods A prospective double-blind sequential study was conducted using 40 children who were scheduled for surgery according to the sequential method.The main outcomes were the oral dose of midazolam that achieved the Parental Separation Anxiety Score(PSAS)of children=130 min after used in combination with intranasal esketamine at a low dose.The secondary outcomes were preoperative systolic blood pressure(SBP),heart rate,sedation level,onset time,preoperative side effects,PSAS scores after administration for 30 min,the Mask Acceptance Scale(MAS)score,the reaction to intravenous cannulation scale(ICS)score,postoperative extubation time,consciousness recovery time,the length of post-anesthesia care unit(PACU)stay,the use of additional analgesic drugs,and the incidence of adverse events such as hypoxemia,nausea and vomiting.The isotonic regression was used to analyze ED90 and its 95%confidence interval(CI).Results The ED90 of oral midazolam that used in combination with 0.25 mg/kg intranasal esketamine for preoperative sedation in children was 0.253(95%CI 0.242-0.278)mg/kg.The average onset time was(8.9±3.8)min.The incidence of hallucinations and excited behavior changes was 7.5%.No children had adverse reactions such as hypoxemia,hypotension,bradycardia,hypertension,tachycardia,nausea and vomiting.Conclusions The combined use of 0.25 mg/kg intranasal esmketamine and oral midazolam can effectively relieve preoperative anxiety in children,and the ED90 of midazolam is 0.253 mg/kg.

关 键 词：艾司氯胺酮 咪达唑仑 镇静 90 有效剂量 小儿 

分 类 号：R726.1[医药卫生—儿科]