Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial.
Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial.
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DOI：
10.1016/s0140-6736(15)00608-x
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发表时间：
2016-01-16
期刊：
影响因子：
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通讯作者：
GAS consortium
中科院分区：
文献类型：
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作者：
Davidson AJ;Disma N;de Graaff JC;Withington DE;Dorris L;Bell G;Stargatt R;Bellinger DC;Schuster T;Arnup SJ;Hardy P;Hunt RW;Takagi MJ;Giribaldi G;Hartmann PL;Salvo I;Morton NS;von Ungern Sternberg BS;Locatelli BG;Wilton N;Lynn A;Thomas JJ;Polaner D;Bagshaw O;Szmuk P;Absalom AR;Frawley G;Berde C;Ormond GD;Marmor J;McCann ME;GAS consortium
有临床前证据表明，全身麻醉影响大脑发育。队列研究中有混合证据表明，暴露于麻醉的幼儿可能会增加神经发育不良的风险。这项试验旨在确定婴儿期GA是否对神经发育结果有任何影响。该试验的主要结局是5岁时的神经发育结局。次要结局是2岁时的神经发育结局，报告如下。我们在胎龄大于26周的经后小于60周的腹股沟疝修补婴儿中进行了一项国际评估者设盲的随机对照等效性试验。如果婴儿存在神经损伤的危险因素，则将其排除。婴儿被随机分配到清醒区域（RA）或七氟烷为基础的全身麻醉（GA）。基于网络的随机化以两个或四个区组进行，并按研究中心和出生时胎龄分层。分析的结果是贝利婴幼儿发展量表第三版的综合认知评分。该分析按方案进行了出生时胎龄调整。将5个点（1/3 SD）的平均值差异预定义为临床等效性界值。该试验在ANZCTR，ACTRN 12606000441516和ClinicalTrials.gov，NCT 00756600上注册。在2007年2月至2013年1月期间，363名婴儿被随机分配到RA组，359名婴儿被随机分配到GA组。RA组238例和GA组294例的结局数据可用。GA组的中位麻醉持续时间为54分钟。对于认知综合评分，两组之间的平均值相等（RA-GA：+0统计169，95%CI −2·30至+2统计64）。对于这一次要结局，我们没有发现任何证据表明，与RA相比，婴儿期七氟烷麻醉不到1小时会增加2岁时不良神经发育结局的风险。
There is pre-clinical evidence that general anaesthetics affect brain development. There is mixed evidence from cohort studies that young children exposed to anaesthesia may have an increased risk of poorer neurodevelopmental outcome. This trial aims to determine if GA in infancy has any impact on neurodevelopmental outcome. The primary outcome for the trial is neurodevelopmental outcome at 5 years of age. The secondary outcome is neurodevelopmental outcome at two years of age and is reported here. We performed an international assessor-masked randomised controlled equivalence trial in infants less than 60 weeks post-menstrual age, born at greater than 26 weeks gestational age having inguinal herniorrhaphy. Infants were excluded if they had existing risk factors for neurologic injury. Infants were randomly assigned to awake-regional (RA) or sevoflurane-based general anaesthesia (GA). Web-based randomisation was performed in blocks of two or four and stratified by site and gestational age at birth. The outcome for analysis was the composite cognitive score of the Bayley Scales of Infant and Toddler Development, Third Edition. The analysis was as-per-protocol adjusted for gestational age at birth. A difference in means of five points (1/3 SD) was predefined as the clinical equivalence margin. The trial was registered at ANZCTR, ACTRN12606000441516 and ClinicalTrials.gov, NCT00756600. Between February 2007, and January 2013, 363 infants were randomised to RA and 359 to GA. Outcome data were available for 238 in the RA and 294 in the GA arms. The median duration of anaesthesia in the GA arm was 54 minutes. For the cognitive composite score there was equivalence in means between arms (RA-GA: +0·169, 95% CI −2·30 to +2·64). For this secondary outcome we found no evidence that just under an hour of sevoflurane anaesthesia in infancy increases the risk of adverse neurodevelopmental outcome at two years of age compared to RA.