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Short-term Outcomes in Infants after General Anesthesia with Low-dose Sevoflurane/Dexmedetomidine/Remifentanil versus Standard-dose Sevoflurane (the TREX Trial).
Anesthesiology ( IF 9.1 ) Pub Date : 2024-12-01 , DOI: 10.1097/aln.0000000000005232
Rita Saynhalath,Nicola Disma,Fiona J Taverner,Britta S von Ungern-Sternberg,Dean Andropoulos,Ann S Ng,Benjamin B Shields,Francesca Izzo,Paul Lee-Archer,Mary Ellen McCann,Luigi Montagnini,Beate Kuppers,Elena Lenares,Suzette Sheppard,Jurgen C de Graaff,Katherine J Lee,Xiaofang Wang,Peter Szmuk,Andrew J Davidson,Justin J Skowno,

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 (89 vs. 4), and protocol abandonments (1 vs. 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. EDITOR’S PERSPECTIVE

中文翻译:


低剂量七氟烷/右美托咪定/瑞芬太尼全身麻醉后婴儿的短期结局与标准剂量七氟烷(TREX 试验)。



背景 瑞芬太尼 DEXmedetomidine (TREX) 试验旨在确定在 2 岁以下儿童中,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。目前的二次分析的目的是比较两组之间术中低血压和心动过缓的发生率、术后疼痛、恢复时间、术中低血压和心动过缓治疗需求、轻度麻醉和治疗需求、术后止痛药需求以及发病率和死亡率结局。方法 该 III 期随机阳性对照、平行组、评估者盲法、多中心、优效性试验在澳大利亚、意大利和美国的 20 个中心进行。共纳入 455 名预计接受全身麻醉至少 2 小时的 2 岁以下婴儿。他们被随机分配到低剂量七氟烷/右美托咪定/瑞芬太尼麻醉和标准剂量七氟烷之间。比较了这两组之间的上述短期围手术期结局。结果与标准剂量七氟烷组相比,低剂量七氟烷/右美托咪定/瑞芬太尼麻醉组的低血压较少(风险差,-11.6%;95% CI,-18.9 至 -4.3%),心动过缓增加(风险差,18.2%;95% CI,8.8 至 27.7%)。在低剂量七氟烷/右美托咪定/瑞芬太尼麻醉组中,轻度麻醉发作 (89 vs. 4) 和方案放弃 (1 vs. 0) 的患者更多。两组从睁眼到麻醉后监护病房出院的时间相似,发病率和死亡率也相似。 每组一名患者遭受了危及生命的事件,但都没有遭受长期后遗症。结论这些早期术后结果表明,在接受全身麻醉超过 2 小时的 2 岁以下儿童中,低剂量七氟烷/右美托咪定/瑞芬太尼麻醉技术和标准七氟烷麻醉技术在临床上大致相似,没有明确的证据支持选择一种技术而不是另一种技术。编辑观点
更新日期:2024-11-13
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