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Short-term outcomes in infants following general anesthesia with low-dose sevoflurane/dexmedetomidine/remifentanil versus standard dose sevoflurane (The TREX trial).
Saynhalath, Rita; Disma, Nicola; Taverner, Fiona J; von Ungern-Sternberg, Britta S; Andropoulos, Dean; Ng, Ann S; Shields, Benjamin B; Izzo, Francesca; Lee-Archer, Paul; McCann, Mary Ellen; Montagnini, Luigi; Kuppers, Beate; Lenares, Elena; Sheppard, Suzette; de Graaff, Jurgen C; Lee, Katherine J; Wang, Xiaofang; Szmuk, Peter; Davidson, Andrew J; Skowno, Justin J.
Afiliación
  • Saynhalath R; 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.
  • Disma N; Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, United States. Member.
  • Taverner FJ; Unit for Research in Anaesthesia, IRCCS Istituto Giannina Gaslini, Genoa, Italy. Anaesthetist. NicolaDisma@Gaslini.org.
  • von Ungern-Sternberg BS; Flinders University, College of Medicine and Public Health, Adelaide, South Australia, Australia, Department of Anaesthesia and Pain Medicine, Flinders Medical Centre, Adelaide, South Australia, Australia, Department of Children's Anaesthesia, Women's and Children's Hospital, North Adelaide, South A
  • Andropoulos D; Department of Anaesthesia and Pain Medicine, Perth Children's Hospital, Perth, WA, Australia.
  • Ng AS; Division of Emergency Medicine, Anaesthesia and Pain Medicine, Medical School, The University of Western Australia, Perth, WA, Australia.
  • Shields BB; Institute for Paediatric Perioperative Excellence, The University of Western Australia, Perth, WA, Australia.
  • Izzo F; Perioperative Medicine Team, Perioperative Care Program, Telethon Kids Institute, Perth, WA, Australia Anaesthetist. Britta.Regli-VonUngern@health.wa.gov.au.
  • Lee-Archer P; Department of Anesthesiology, Texas Children's Hospital and Baylor College of Medicine, Houston, Texas, United States. Anesthesiologist-in-Chief. dbandrop@texaschildrens.org.
  • McCann ME; Department of Anesthesiology, Texas Children's Hospital and Baylor College of Medicine, Houston, Texas, United States. Anesthesiologist. atxann18@gmail.com.
  • Montagnini L; Department of Anesthesiology, Texas Children's Hospital and Baylor College of Medicine, Houston, Texas, United States. Anesthesiologist. ben.shields@bcm.edu.
  • Kuppers B; Department of Pediatric Anesthesia and Intensive Care, Children's Hospital "Vittore Buzzi", Milan, Italy. Anaesthetist. francesca.izzo@asst-fbf-sacco.it.
  • Lenares E; Department of Anaesthesia, Queensland Children's Hospital. Faculty of Medicine, University of Queensland. Senior Staff Anaesthetist. Paul.Lee-Archer@health.qld.gov.au.
  • Sheppard S; Department of Anesthesiology, Pain and Perioperative Medicine, Boston Children's Hospital, Boston, Massachusetts, United States. Anesthesiologist. MaryEllen.McCann@childrens.harvard.edu.
  • de Graaff JC; Servizio Anestesia e Rianimazione 1, Dipartimento Emergenza Urgenza. Grande Ospedale Metropolitano Niguarda, Milano, Italy. Anaesthetist. luigi.montagnini@ospedaleniguarda.it.
  • Lee KJ; Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. Anaesthetist. b.kuppers@ao-pisa.toscana.it.
  • Wang X; AOU A. Meyer, Florence, Italy. Anaesthetist. e.lenares@meyer.it.
  • Szmuk P; Department of Anaesthesia, The Royal Children's Hospital, Victoria, Australia. Anaesthesia Research Group, Murdoch Children's Research Institute, Victoria, Australia. Research Coordinator. Suzette.sheppard@mcri.edu.au.
  • Davidson AJ; Department of Anesthesiology, ADRZ-Erasmus MC, Goes, the Netherlands. Anesthesiologist. Department of Anesthesiology, Weill Cornell Medicine, New York, New York, United States. Anesthesiologist. j.degraaff@erasmusmc.nl.
  • Skowno JJ; Clinical Epidemiology and Biostatistics Unit and Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Victoria, Australia. Department of Paediatrics, University of Melbourne, Victoria, Australia. Biostatistician. katherine.lee@mcri.edu.au.
Anesthesiology ; 2024 Sep 16.
Article en En | MEDLINE | ID: mdl-39283983
ABSTRACT

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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Anesthesiology Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Anesthesiology Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos