Journal article
Dexamethasone and surgical-site infection
New England Journal of Medicine, Vol.384(18), pp.1731-1741
2021
Abstract
BACKGROUND
The glucocorticoid dexamethasone prevents nausea and vomiting after surgery, but there is concern that it may increase the risk of surgical-site infection.
METHODS
In this pragmatic, international, noninferiority trial, we randomly assigned 8880 adult patients who were undergoing nonurgent, noncardiac surgery of at least 2 hours’ duration, with a skin incision length longer than 5 cm and a postoperative overnight hospital stay, to receive 8 mg of intravenous dexamethasone or matching placebo while under anesthesia. Randomization was stratified according to diabetes status and trial center. The primary outcome was surgical-site infection within 30 days after surgery. The prespecified noninferiority margin was 2.0 percentage points.
RESULTS
A total of 8725 participants were included in the modified intention-to-treat population (4372 in the dexamethasone group and 4353 in the placebo group), of whom 13.2% (576 in the dexamethasone group and 572 in the placebo group) had diabetes mellitus. Of the 8678 patients included in the primary analysis, surgical-site infection occurred in 8.1% (354 of 4350 patients) assigned to dexamethasone and in 9.1% (394 of 4328) assigned to placebo (risk difference adjusted for diabetes status, −0.9 percentage points; 95.6% confidence interval [CI], −2.1 to 0.3; P<0.001 for noninferiority). The results for superficial, deep, and organ-space surgical-site infections and in patients with diabetes were similar to those of the primary analysis. Postoperative nausea and vomiting in the first 24 hours after surgery occurred in 42.2% of patients in the dexamethasone group and in 53.9% in the placebo group (risk ratio, 0.78; 95% CI, 0.75 to 0.82). Hyperglycemic events in patients without diabetes occurred in 22 of 3787 (0.6%) in the dexamethasone group and in 6 of 3776 (0.2%) in the placebo group.
CONCLUSIONS
Dexamethasone was noninferior to placebo with respect to the incidence of surgical-site infection within 30 days after nonurgent, noncardiac surgery. (Funded by the Australian National Health and Medical Research Council and others; PADDI Australian New Zealand Clinical Trials Registry number, ACTRN12614001226695. opens in new tab.)
Details
- Title
- Dexamethasone and surgical-site infection
- Authors/Creators
- T.B. Corcoran (Author/Creator)P.S. Myles (Author/Creator)A.B. Forbes (Author/Creator)A.C. Cheng (Author/Creator)L.A. Bach (Author/Creator)E. O’Loughlin (Author/Creator)K. Leslie (Author/Creator)M.T.V. Chan (Author/Creator)D. Story (Author/Creator)T.G. Short (Author/Creator)C. Martin (Author/Creator)P. Coutts (Author/Creator)K.M. Ho (Author/Creator)
- Publication Details
- New England Journal of Medicine, Vol.384(18), pp.1731-1741
- Publisher
- Massachusetts Medical Society
- Identifiers
- 991005544942407891
- Copyright
- © 2021 Massachusetts Medical Society.
- Murdoch Affiliation
- School of Veterinary and Life Sciences
- Language
- English
- Resource Type
- Journal article
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- Domestic collaboration
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- Citation topics
- 1 Clinical & Life Sciences
- 1.43 Anesthesiology
- 1.43.1482 Antiemetics
- Web Of Science research areas
- Anesthesiology
- ESI research areas
- Clinical Medicine