Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial - CNRS - Centre national de la recherche scientifique Accéder directement au contenu
Article Dans Une Revue BMJ - British Medical Journal Année : 2021

Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial

Karim Asehnoune
  • Fonction : Auteur
Charlene Le Moal
  • Fonction : Auteur
Gilles Lebuffe
  • Fonction : Auteur
Marguerite Le Penndu
  • Fonction : Auteur
Nolwen Chatel Josse
  • Fonction : Auteur
Thomas Lescot
  • Fonction : Auteur
Marion Faucher
Thomas Godet
Cyrus Motamed
  • Fonction : Auteur
Jean Stephane David
  • Fonction : Auteur
Raphael Cinotti
Younes El Amine
  • Fonction : Auteur
Darius Liutkus
  • Fonction : Auteur
Matthias Garot
  • Fonction : Auteur
Antoine Marc
  • Fonction : Auteur
Anne Le Corre
  • Fonction : Auteur
Alexandre Thomasseau
  • Fonction : Auteur
Laurent Flet
  • Fonction : Auteur
Fanny Feuillet
Morgane Pere
  • Fonction : Auteur
Emmanuel Futier
Antoine Roquilly

Résumé

Abstract Objective To assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery. Design Phase III, randomised, double blind, placebo controlled trial. Setting 34 centres in France, December 2017 to March 2019. Participants 1222 adults (>50 years) requiring major non-cardiac surgery with an expected duration of more than 90 minutes. The anticipated time frame for recruitment was 24 months. Interventions Participants were randomised to receive either dexamethasone (0.2 mg/kg immediately after the surgical procedure, and on day 1) or placebo. Randomisation was stratified on the two prespecified criteria of cancer and thoracic procedure. Main outcomes measures The primary outcome was a composite of postoperative complications or all cause mortality within 14 days after surgery, assessed in the modified intention-to-treat population (at least one treatment administered). Results Of the 1222 participants who underwent randomisation, 1184 (96.9%) were included in the modified intention-to-treat population. 14 days after surgery, 101 of 595 participants (17.0%) in the dexamethasone group and 117 of 589 (19.9%) in the placebo group had complications or died (adjusted odds ratio 0.81, 95% confidence interval 0.60 to 1.08; P=0.15). In the stratum of participants who underwent non-thoracic surgery (n=1038), the primary outcome occurred in 69 of 520 participants (13.3%) in the dexamethasone group and 93 of 518 (18%) in the placebo group (adjusted odds ratio 0.70, 0.50 to 0.99). Adverse events were reported in 288 of 613 participants (47.0%) in the dexamethasone group and 296 of 609 (48.6%) in the placebo group (P=0.46). Conclusions Dexamethasone was not found to significantly reduce the incidence of complications and death in patients 14 days after major non-cardiac surgery. The 95% confidence interval for the main result was, however, wide and suggests the possibility of important clinical effectiveness. Trial registration ClinicalTrials.gov NCT03218553 .
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Dates et versions

hal-03258675 , version 1 (12-06-2021)

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Karim Asehnoune, Charlene Le Moal, Gilles Lebuffe, Marguerite Le Penndu, Nolwen Chatel Josse, et al.. Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial. BMJ - British Medical Journal, 2021, 373, pp.n1162. ⟨10.1136/bmj.n1162⟩. ⟨hal-03258675⟩
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