幼儿行全麻和清醒的区域麻醉后血压的差异(GAS研究 - 前瞻性随机试验)

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Differences in Blood Pressure in Infants After General Anesthesia Compared to Awake Regional Anesthesia (GAS Study—A Prospective Randomized Trial)

背景与目的

全身麻醉与脊髓麻醉对比(GAS)的研究,是一项多中心的前瞻性随机对照试验,旨在评估全身麻醉(GA)对5岁以下儿童神经发育的影响。次要目的是从全麻与腰麻对比试验研究的血压数据中获得其术中低血压的发生率,进行比较并确定术中发生低血压的危险因素。

方  法

将722名小于或等于60周龄行腹股沟疝修补术的婴儿随机分到布比卡因区域麻醉(RA)组或七氟醚全麻组。排除标准包括:会导致神经发育不良的危险因素和妊娠<26周时出生的婴儿。中度低血压定义为测量的平均动脉压<35 mm Hg。只要平均动脉压<45 mm Hg即被定义为低血压。测量周期为5分钟。主要结果是从开始麻醉到离开手术室的任何时间测得的血压<35mm Hg。该分析主要采用意向性分析(ITT),其次遵循研究方案分析。

结  果

从麻醉开始到离开手术室这期间测量的平均动脉压低于<35mm Hg即低血压的发生情况如下:与RA组相比,GA组的相对危险度采用ITT分析得到2.8(置信区间[CI],2.0-4.1; P <0.001)和遵循研究方案分析得到4.5(CI,2.7-7.4,P <0.001)。ITT分析显示的低血压或中度低血压发生率在GA组中分别为87%和49%,RA组分别为41%和16%。在多变量模型中,分组(GA对RA)、手术时的体重和术中的最低体温值都是发生低血压的危险因素。与RA组相比,GA组需要对低血压进行干预的例数更多(ITT分析得:相对危险度为2.8%,95%CI为1.7-4.4)。

结  论

在接受腹股沟疝修补的小婴儿中,与七氟烷全麻相比,RA可以降低低血压发生率和需要干预治疗的机会。

原始文献摘要

McCann, M. Withington, D. Arnup, S.et al.Differences in Blood Pressure in Infants After General Anesthesia Compared to Awake Regional Anesthesia (GAS Study—A Prospective Randomized Trial).Anesthesia & Analgesia: September 2017 - Volume 125 - Issue 3 - p 837–845.doi: 10.1213/ANE.0000000000001870

BACKGROUND: The General Anesthesia compared to Spinal anesthesia (GAS) study is a prospective randomized, controlled, multisite, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment at 5 years of age. A secondary aim obtained from the blood pressure data of the GAS trial is to compare rates of intraoperative hypotension after anesthesia and to identify risk factors for intraoperative hypotension.

METHODS: A total of 722 infants ≤60 weeks postmenstrual age undergoing inguinal herniorrhaphy were randomized to either bupivacaine regional anesthesia (RA) or sevoflurane GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born at <26 weeks of gestation. Moderate hypotension was defined as mean arterial pressure measurement of <35 mm Hg. Any hypotension was defined as mean arterial pressure of <45 mm Hg. Epochs were defined as 5-minute measurement periods. The primary outcome was any measured hypotension <35 mm Hg from start of anesthesia to leaving the operating room. This analysis is reported primarily as intention to treat (ITT) and secondarily as per protocol.

RESULTS: The relative risk of GA compared with RA predicting any measured hypotension of <35 mm Hg from the start of anesthesia to leaving the operating room was 2.8 (confidence interval [CI], 2.0–4.1; P < .001) by ITT analysis and 4.5 (CI, 2.7–7.4, P < .001) as per protocol analysis. In the GA group, 87% and 49%, and in the RA group, 41% and 16%, exhibited any or moderate hypotension by ITT, respectively. In multivariable modeling, group assignment (GA versus RA), weight at the time of surgery, and minimal intraoperative temperature were risk factors for hypotension. Interventions for hypotension occurred more commonly in the GA group compared with the RA group (relative risk, 2.8, 95% CI, 1.7–4.4 by ITT).

CONCLUSIONS: RA reduces the incidence of hypotension and the chance of intervention to treat it compared with sevoflurane anesthesia in young infants undergoing inguinal hernia repair.

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