摘要译文(供参考)
低剂量七氟醚/右美托咪定/瑞芬太尼与标准剂量七氟醚全麻后婴儿的短期结局(TREX试验)
背景:TREX(瑞芬太尼右美托咪定试验)试验旨在确定在<2岁儿童中,低剂量七氟醚/右美托咪定/瑞芬太尼麻醉(LD-SEVO)在3岁时整体认知功能方面是否优于标准剂量七氟醚(STD-SEVO)麻醉。本次次要分析的目的是比较两组间术中低血压和心动过缓的发生率、术后疼痛、恢复时间、治疗术中低血压和心动过缓的需要、轻度麻醉的发生率和治疗需要、术后止痛药的需要以及5天时的发病率和死亡率结局。
方法:在澳大利亚、意大利和美国的20个中心进行了这项III期随机、活性对照、平行组、评估者设盲、多中心、优效性试验。入组了455名2岁以下预期接受至少2小时全身麻醉的婴儿。将患者随机分为LD-SEVO组和STD-SEVO组,比较两组的近期围手术期结局。
结果:与STD-SEVO组相比,LD-SEVO组低血压(风险差异-11.6%,95%置信区间(CI)-18.9%-4.3%)和心动过缓(风险差异18.2%,95%CI8.8%-27.7%)较少。LD-SEVO组轻度麻醉发作(89vs.4)和方案放弃(1vs.0)的患者较多。两组从睁眼到麻醉后监护室(PACU)出院的时间相似,发病率和死亡率相似,每组各有1例患者发生危及生命事件,但均未发生长期后遗症。
结论:这些早期术后结果表明,在接受超过2小时全身麻醉的2岁以下儿童中,低剂量七氟烷/右美托咪定/瑞芬太尼麻醉技术与标准七氟烷麻醉技术在临床上大体相似,没有明确证据支持选择一种方法而不是另一种方法。
原文摘要
Short-term outcomes in infants following general anesthesia with low-dose sevoflurane/dexmedetomidine/remifentanil versus standard dose sevoflurane (The TREX trial)
Background: The TREX (Trial Remifentanil DEXmedetomidine) trial aimed to determine if, in children < 2 years old, low-dose sevoflurane/dexmedetomidine/remifentanil anesthesia (LD-SEVO) is superior to standard dose sevoflurane (STD-SEVO) anesthesia in terms of global cognitive function at 3 years of age. The aim of the present secondary analyses was to compare incidence of intraoperative hypotension and bradycardia, postoperative pain, time to recovery, need for treatment of intraoperative hypotension and bradycardia, incidence of light anesthesia and need for treatment, need for postoperative pain medications, and morbidity and mortality outcomes at 5 days between the two arms.
Methods: This Phase III randomized active controlled, parallel group, assessor blinded, multicenter, superiority trial was performed in 20 centers in Australia, Italy, and the United States. Four hundred and fifty-five infants <2 years of age expected to undergo general anesthesia for at least 2 hours were enrolled. They were randomized between LD-SEVO and STD-SEVO. The short-term perioperative outcomes noted above were compared between these two groups.
Results: There was less hypotension (risk difference -11.6%, 95% confidence interval (CI) -18.9% to -4.3%) and more bradycardia (risk difference 18.2%, 95% CI 8.8% to 27.7%) in the LD-SEVO compared to the STD-SEVO arm. There were more patients with episodes of light anesthesia (89 vs. 4), and protocol abandonments (1 vs. 0) in the LD-SEVO arm. Time from eye-opening to Post Anesthesia Care Unit (PACU) discharge was similar in both arms, as were morbidity and mortality. One patient in each arm suffered a life-threatening event but neither suffered long-term sequelae.
Conclusions: These early postoperative results suggest that in children less than 2 years of age receiving greater than 2 hours of general anesthesia, the low-dose sevoflurane/dexmedetomidine/remifentanil anesthesia technique and the standard sevoflurane anesthesia technique are broadly clinically similar, with no clear evidence to support choosing one technique over the other.