Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Korea.
Interdisciplinary Program in Medical Informatics, Seoul National University Graduate School, Seoul, Korea.
J Korean Med Sci. 2019 Apr 22;34(15):e124. doi: 10.3346/jkms.2019.34.e124.
Despite well-known advantages, propofol remains off-label in many countries for general anesthesia in children under 3 years of age due to insufficient evidence regarding its use in this population. This study aimed to evaluate the efficacy and safety of propofol compared with other general anesthetics in children under 3 years of age undergoing surgery through a systematic review and meta-analysis of existing randomized clinical trials.
A comprehensive literature search was conducted of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to find all randomized clinical trials comparing propofol with another general anesthetic that included children under 3 years of age. The relative risk or arcsine-transformed risk difference for dichotomous outcomes and the weighted or standardized mean difference for continuous outcomes were estimated using a random-effects model.
A total of 249 young children from 6 publications were included. The children who received propofol had statistically significantly lower systolic and diastolic blood pressures, but hypotension was not observed in the propofol groups. The heart rate, stroke volume index, and cardiac index were not significantly different between the propofol and control groups. The propofol groups showed slightly shorter recovery times and a lower incidence of emergence agitation than the control groups, while no difference was observed for the incidence of hypotension, desaturation, and apnea.
This systematic review and meta-analysis indicates that propofol use for general anesthesia in young healthy children undergoing surgery does not increase complications and that propofol could be at least comparable to other anesthetic agents.
尽管丙泊酚有众所周知的优势,但由于在该人群中使用的证据不足,丙泊酚在许多国家仍被禁止用于 3 岁以下儿童的全身麻醉。本研究旨在通过对现有随机临床试验进行系统评价和荟萃分析,评估丙泊酚在 3 岁以下儿童手术中相对于其他全身麻醉药的疗效和安全性。
对 MEDLINE、Embase 和 Cochrane 对照试验中心注册库进行全面文献检索,以查找所有比较丙泊酚与另一种全身麻醉药的随机临床试验,这些试验均纳入了 3 岁以下的儿童。使用随机效应模型估计二分类结局的相对风险或反正弦转换的风险差,以及连续结局的加权或标准化均数差。
共有来自 6 篇文献的 249 名幼儿被纳入。接受丙泊酚的患儿的收缩压和舒张压明显较低,但丙泊酚组未观察到低血压。丙泊酚组和对照组的心率、每搏量指数和心排指数无显著差异。丙泊酚组的恢复时间较短,出现苏醒躁动的发生率较低,而低血压、低氧血症和呼吸暂停的发生率无差异。
本系统评价和荟萃分析表明,丙泊酚用于手术中健康幼儿的全身麻醉不会增加并发症,并且丙泊酚至少可与其他麻醉剂相媲美。