【罂粟摘要】低剂量七氟烷/右美托咪啶/瑞芬太尼与标准剂量七氟烷全麻后婴幼儿的短期结局差异

该试验旨在确定2岁以下的婴幼儿中，低剂量七氟烷/右美托咪定/瑞芬太尼麻醉在3岁时的整体认知功能方面是否优于标准剂量七氟烷麻醉。本次主要比较两组患者术中低血压和心动过缓的发生率、术后疼痛、恢复时间、术中低血压与心动过缓治疗的需求、浅麻醉的发生率和治疗需求、术后止痛药的需求、术后5天的发病率和死亡率等结果。

这项III期随机、对照、平行、盲法、多中心、优越性试验在澳大利亚、意大利和美国的20个中心进行。共招募了455名2岁以下的婴幼儿，预计将接受至少2小时的全身麻醉。他们被随机分配到低剂量七氟烷/右美托咪啶/瑞芬太尼麻醉组和标准剂量七氟烷麻醉组。对两组围手术期短期结果进行比较。

与标准剂量七氟烷麻醉相比，低剂量七氟烷/右美托咪啶/瑞芬太尼麻醉的低血压较少（风险差异为-11.6%；95%置信区间为-18.9%至-4.3%），心动过缓较多（风险差异18.2%；95%可信区间为8.8至27.7%）。在低剂量七氟烷/右美托咪啶/瑞芬太尼麻醉组中，更多的患者发生浅麻醉（89 VS 4）。两组患者从睁眼到出麻醉恢复室的时间相似，发病率和死亡率也相似。每组各有一名患者出现危及生命的事件，但均未出现长期后遗症。

在接受2小时以上全身麻醉的2岁以下婴幼儿中，低剂量七氟烷/右美托咪啶/瑞芬太尼麻醉和标准七氟烷麻醉在临床结局上大致相似，没有明确的证据支持选择哪一种技术更优。

原始文献来源：Rita, Saynhalath;  Nicola, Disma;  Fiona J, Taverner;  Britta S, von Ungern-Sternberg; Short-term Outcomes in Infants after General Anesthesia with Low-dose Sevoflurane /Dexmedetomidine/ Remifentanil versus Standard-dose Sevoflurane (the TREX Trial)；Anesthesiology 2024 Dec 1;141(6):1075-1085PMID：39283983

Short-term Outcomes in Infants after General Anesthesia with Low-dose Sevoflurane /Dexmedetomidine/ Remifentanil versus Standard-dose Sevoflurane (the TREX Trial)

BACKGROUND: The Trial Remifentanil DEXmedetomidine (TREX) trial aimed to determine whether, in children less than 2 yr old, low-dose sevoflurane/dexmedetomidine/remifentanil anesthesia is superior to standard-dose sevoflurane anesthesia in terms of global cognitive function at 3 yr of age. The aim of the current 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. A total of 455 infants less than 2 yr of age expected to undergo general anesthesia for at least 2 h were enrolled. They were randomized between low-dose sevoflurane/dexmedetomidine/remifentanil anesthesia and standard-dose sevoflurane. The short-term perioperative outcomes noted above were compared between these two groups.

RESULTS: There was less hypotension (risk difference, -11.6%; 95% CI, -18.9 to -4.3%) and more bradycardia (risk difference, 18.2%; 95% CI, 8.8 to 27.7%) in the low-dose sevoflurane/dexmedetomidine/remifentanil anesthesia compared to the standard-dose sevoflurane arm. There were more patients with episodes of light anesthesia (89vs.4), and protocol abandonments (1vs. 0) in the low-dose sevoflurane/dexmedetomidine/remifentanil anesthesia arm. Time from eye opening to postanesthesia care unit 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 yr of age receiving greater than 2 h 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.