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

Media type: E-Article
Title: Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial
Contributor: Asehnoune, Karim; Le Moal, Charlene; Lebuffe, Gilles; Le Penndu, Marguerite; Josse, Nolwen Chatel; Boisson, Matthieu; Lescot, Thomas; Faucher, Marion; Jaber, Samir; Godet, Thomas; Leone, Marc; Motamed, Cyrus; David, Jean Stephane; Cinotti, Raphael; El Amine, Younes; Liutkus, Darius; Garot, Matthias; Marc, Antoine; Le Corre, Anne; Thomasseau, Alexandre; Jobert, Alexandra; Flet, Laurent; Feuillet, Fanny; Pere, Morgane; [...]
Published: BMJ, 2021
Published in: BMJ (2021), Seite n1162
Language: English
DOI: 10.1136/bmj.n1162
ISSN: 1756-1833
Origination:
Footnote:
Description: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Objective</jats:title> <jats:p>To assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery.</jats:p> </jats:sec> <jats:sec> <jats:title>Design</jats:title> <jats:p>Phase III, randomised, double blind, placebo controlled trial.</jats:p> </jats:sec> <jats:sec> <jats:title>Setting</jats:title> <jats:p>34 centres in France, December 2017 to March 2019.</jats:p> </jats:sec> <jats:sec> <jats:title>Participants</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Interventions</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Main outcomes measures</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial registration</jats:title> <jats:p> ClinicalTrials.gov <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT03218553" ext-link-type="clintrialgov">NCT03218553</jats:ext-link> . </jats:p> </jats:sec>

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