• Anesthesiology · Sep 2024

    Short-term outcomes in infants following general anesthesia with low-dose sevoflurane/dexmedetomidine/remifentanil versus standard dose sevoflurane (The TREX trial).

    • 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, and TREX (Trial Remifentanil DEXmedetomidine) consortium..
    • Department of Anesthesiology and Pain Management, University of Texas Southwestern and Children's Health, Dallas, Texas, United States. Associate professor and pediatric anesthesiologist. Rita.Saynhalath@UTSouthwestern.edu.
    • Anesthesiology. 2024 Sep 16.

    BackgroundThe 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.MethodsThis 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.ResultsThere 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.ConclusionsThese 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.Copyright © 2024 American Society of Anesthesiologists. All Rights Reserved.

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