• Anesthesiology · Dec 2024

    Randomized Controlled Trial Multicenter Study Comparative Study

    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; and Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio.
    • Anesthesiology. 2024 Dec 1; 141 (6): 107510851075-1085.

    BackgroundThe 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.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. 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.ResultsThere 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.ConclusionsThese 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.Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc., on behalf of the American Society of Anesthesiologists.

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