Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial
Related Experiment Video
Updated: Nov 3, 2025
Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
Karim Asehnoune1, Charlene Le Moal2, Gilles Lebuffe3
1CHU Nantes, Université de Nantes, Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu, Nantes, France karim.asehnoune@chu-nantes.fr.
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.
More Related Videos
05:39Author Spotlight: A Non-Intubated Video-Assisted Thoracoscopic Surgery with Multimodal Analgesia and Sevoflurane Inhalation Anesthesia
Published on: May 26, 2023
06:55A Surgical Procedure for the Administration of Drugs to the Inner Ear in a Non-Human Primate Common Marmoset Callithrix jacchus
Published on: February 27, 2018
Related Concept Videos
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:21Skeletal Muscle Relaxants: Adverse Effects
Unlike...
01:21Drug Dosing: Obese Patients
01:11Clinical Trials: Overview