Dexamethasone non-inferior to placebo for surgical-site infection incidence

1. Intraoperative dexamethasone was shown to be non-inferior to placebo for surgical-site infection incidence.

2. Intraoperative dexamethasone was shown to lower postoperative nausea and vomiting 24 hours after the surgery.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Dexamethasone prevents postoperative nausea and vomiting; however, there are concerns regarding the increased risk of infection. As such, this randomized controlled trial studied the incidence of surgical-site infection from the use of intraoperative dexamethasone and placebo. In patients undergoing nonurgent, noncardiac surgery, the study found surgical-site infection occurred at comparable rates between the dexamethasone- and placebo-treated groups. Detailed examinations of superficial, deep, and organ-space infections and other safety measures yielded similar results. In diabetic patients, dexamethasone did not lead to increased risk of surgical-site infection; however, hyperglycemic events were more prevalent in dexamethasone-treated patients. The study was limited by the nonadherence to the assigned treatments resulting in a biased analysis. Nonetheless, the trial demonstrated the noninferiority of dexamethasone in infection risks compared to the placebo.

Click here to read the study in NEJM

Relevant Reading: Intraoperative dexamethasone does not increase the risk of postoperative wound infection: a propensity score-matched post hoc analysis of the ENIGMA-II trial (EnDEX)

In-Depth [randomized controlled trial]: This randomized controlled trial enrolled 8,725 patients in Australia and New Zealand. Patients with an expected surgery duration of at least two hours, a postoperative inpatient stay of at least one night, and an incision length of more than five centimeters were included in the study. Patients were excluded if their surgery was urgent or if they required intraoperative dexamethasone. Patients were randomized in a 1:1 ratio to receive either intravenous eight milligrams of dexamethasone or placebo, respectively. The primary outcome was the rate of surgical-site infection within 30 days after the procedure, including superficial, deep, and organ-space infections. At 30 days, 8.1% of the dexamethasone group and 9.1% of patients in the placebo group developed surgical-site infection (risk ratio [RR], 0.89; 95.6% confidence interval [CI], 0.77 to 1.03; P < 0.001). Nausea and vomiting within 24 hours after surgery was reduced by dexamethasone (RR, 0.78; 95% CI, 0.75 to 0.82). Hyperglycemic events were more prevalent in the dexamethasone group and were manageable by insulin. This large trial established the noninferiority of intraoperative dexamethasone in patients with or without diabetes in a range of surgical procedures in infection outcomes and supported its use in reducing postoperative nausea.

Image: PD

©2021 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.