Dexamethasone and Surgical-Site Infection
| Autor: | Edmond O’Loughlin, Matthew T. V. Chan, Kate Leslie, Allen C. Cheng, Andrew Forbes, Catherine Martin, Leon A. Bach, Timothy G. Short, Pauline Coutts, Kwok M. Ho, Paul S. Myles, Tomas Corcoran, David A Story |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male Adolescent Nausea Anesthesia General 030204 cardiovascular system & hematology Dexamethasone Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Risk Factors Diabetes mellitus medicine Humans Surgical Wound Infection 030212 general & internal medicine Glucocorticoids Aged Aged 80 and over Intention-to-treat analysis business.industry General Medicine Middle Aged medicine.disease Intention to Treat Analysis Clinical research Surgical Procedures Operative Anesthesia Vomiting Antiemetics Female medicine.symptom business Glucocorticoid Postoperative nausea and vomiting medicine.drug |
| Zdroj: | New England Journal of Medicine. 384:1731-1741 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa2028982 |
| Popis: | The glucocorticoid dexamethasone prevents nausea and vomiting after surgery, but there is concern that it may increase the risk of surgical-site infection.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.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; P0.001 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.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.). |
| Databáze: | OpenAIRE |
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