Key result
Dexamethasone did not significantly reduce postoperative complications or mortality at 14 days after major non-cardiac surgery compared to placebo (OR 0.81; 95% CI 0.60-1.08; P=0.15).
Why the study?
The study was conducted to evaluate the effect of dexamethasone on postoperative complications and all-cause mortality after major non-cardiac surgery.
Does dexamethasone reduce postoperative complications or all-cause mortality in adults undergoing major non-cardiac surgery?
RCT (n=1,222)
Double-blind
Stratified on cancer and thoracic procedure
Yes
Does dexamethasone reduce postoperative complications or all-cause mortality in adults undergoing major non-cardiac surgery?
Perioperative dexamethasone did not significantly reduce the 14-day composite of complications or mortality after major non-cardiac surgery, though the wide confidence interval suggests a potential clinically important benefit cannot be ruled out.
Does not support routine perioperative dexamethasone to reduce complications after major non-cardiac surgery; leaves open a potential benefit given the wide CI.
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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Asehnoune et al. (2021) conducted an RCT in Major non-cardiac surgery (n=1,222). Dexamethasone vs. Placebo was evaluated on Composite of postoperative complications or all cause mortality within 14 days after surgery (adjusted OR 0.81, 95% CI 0.60 to 1.08, p=0.15). Dexamethasone did not significantly reduce postoperative complications or mortality at 14 days after major non-cardiac surgery compared to placebo (OR 0.81; 95% CI 0.60-1.08; P=0.15).
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