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Title: | Intraoperative dexamethasone does not increase the risk of postoperative wound infection: A propensity score-matched post hoc analysis of the ENIGMA-II trial (EnDEX). | Authors: | Iannuzzi D.;Corcoran T.;Kasza J.;Short T.G.;O'Loughlin E.;Chan M.;Leslie K.;Forbes A.;Paech M.;Myles P.;Wallace S.;Galagher W.;Farrington C.;Ditoro A.;Peyton P.;Baulch S.;Sidiropoulos S.;Bulach R. ;Bryant D.;Mitteregger V.;Bolsin S.;Osborne C.;McRae R.;Backstrom M.;Cotter R.;March S.;Silbert B.;Said S.;Halliwell R.;Cope J.;Fahlbusch D.;Crump D.;Thompson G.;Jefferies A.;McCulloch T.;Reeves M.;Buckley N.;Tidyl T.;Schricker T.;Lattermann R.;Beattie S.;Carroll J.;Jacka M.;Bryden C.;Badner N.;Tsang M.;Cheng B.;Fong A. ;Chu L.;Koo E.;Mohd N.;Ming L.E.;Yin Wang C.;Campbell D.;McAllister D.;Walker S.;Olliff S.;Kennedy R.;Eldawlatly A.;Alzahrani T.;Chua N.;Haller G.;Pichon I.;Sneyd R.;McMillan H.;Parkinson I.;Rousseau G.;Brennan A.;Balaji P.;Cupitt J.;Nightingale J.;Kunst G.;Dickinson M.;Saran T.;Subramaniam B.;Banner-Godspeed V.;Sessler D.;Liu J.;Kurz A.;Hesler B.;Fu A.;Egan C.;Fiffick A.;Hutcherson M.;Turan A.;Naylor A.;Obal D.;Cooke E. | Institution: | (Corcoran, Paech) Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, WA, Australia (Corcoran, O'Loughlin, Paech) School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia (Corcoran) Western Australia Health Department, Perth, WA, Australia (Corcoran, Kasza, Leslie, Forbes, Myles) Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (Short) Department of Anaesthesia, Auckland City Hospital, Park Road, Grafton, Auckland, New Zealand (O'Loughlin) Department of Anaesthesia and Pain Medicine, Fiona Stanley Hospital, Perth, WA, Australia (Chan) Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong (Leslie) Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, VIC, Australia (Leslie) Anaesthesia Perioperative and Pain Medicine Unit, Department of Pharmacology and Therapeutics, University of Melbourne, Melbourne, VIC, Australia (Myles) Department of Anaesthesia and Perioperative Medicine, Alfred Hospital, Melbourne, VIC, Australia (Wallace, Galagher, Farrington, Ditoro) AustinAustralia (Peyton, Baulch, Sidiropoulos) DandenongAustralia (Bulach, Bryant) Fremantle, Australia (O'Loughlin, Mitteregger) Geelong Hospital, Australia (Bolsin, Osborne) Monash Medical Centre, Australia (McRae, Backstrom) Royal Melbourne Hospital, Australia (Leslie, Cotter) Royal Perth Hospital, Australia (Paech, March) St Vincent's Hospital, Australia (Silbert, Said) Westmead Hospital, Australia (Halliwell, Cope) Calvary WakefieldAustralia (Fahlbusch, Crump) Peter MacCallum Cancer Centre, Australia (Thompson) Western Hospital, Australia (Jefferies) Royal Prince Alfred, Australia (McCulloch) North West Regional Hosptial, Australia (Reeves) McMaster University, Canada (Buckley, Tidyl) Royal Victoria Hospital, Canada (Schricker, Lattermann, Iannuzzi) Toronto General Hospital, Canada (Beattie, Carroll) University of Alberta Hospital, Canada (Jacka, Bryden) London Health Sciences, Canada (Badner) Prince of Wales, Hong Kong (Chan) ANZCA Trials Group Member, Hong Kong (Tsang) Tuen Mun Hospital, Hong Kong (Cheng, Fong) ACM Fong, Hong Kong (Chu, Koo) Nethersole Eastern Hospital, Hong Kong (Mohd, Ming) Hospital Kuala Lumpur, Malaysia (Yin Wang) Malaya Medical Centre, Malaysia (Campbell, McAllister) Auckland Hospital, New Zealand (Walker, Olliff) Middlemore Hospital, New Zealand (Kennedy) Christchurch Hospital, New Zealand (Eldawlatly, Alzahrani) King Saud University Hospital, Saudi Arabia (Chua) Tan Tock Seng Hospital, Singapore (Haller, Pichon) Geneva University Hospital, Switzerland (Sneyd, McMillan) Plymouth NHS Trust, France (Parkinson) Royal Lancaster Infirmary, United Kingdom (Rousseau) North Devon District Hospital, United Kingdom (Brennan) Bradford Teaching Hospital, United Kingdom (Balaji) Hull Royal Infirmary, United Kingdom (Cupitt) Blackpool Victoria Hospital, United Kingdom (Nightingale) Portsmouth Hospital, United Kingdom (Kunst) King's College Hospital, United Kingdom (Dickinson) Royal Surrey County Hospital, United Kingdom (Saran) University Hospitals, Coventry and Warwickshire, United Kingdom (Subramaniam, Banner-Godspeed) Beth Israel Deaconess Medical Center, United States (Sessler, Liu, Kurz, Hesler, Fu, Egan, Fiffick, Hutcherson, Turan, Naylor) Cleveland Clinic, United States (Obal, Cooke) Louisville Medical Centre, United States | Issue Date: | 22-Jun-2017 | Copyright year: | 2017 | Publisher: | Elsevier Ltd | Place of publication: | United Kingdom | Publication information: | British Journal of Anaesthesia. 118 (2) (pp 190-199), 2017. Date of Publication: 01 Feb 2017. | Journal: | British Journal of Anaesthesia | Abstract: | Background. In a post hoc analysis of the ENIGMA-II trial, we sought to determine whether intraoperative dexamethasone was associated with adverse safety outcomes. Methods. Inverse probability weighting with estimated propensity scores was used to determine the association of dexamethasone administration with postoperative infection, quality of recovery, and adverse safety outcomes for 5499 of the 7112 non-cardiac surgery subjects enrolled in ENIGMA-II. Results. Dexamethasone was administered to 2178 (40%) of the 5499 subjects included in this analysis and was not associated with wound infection [189 (8.7%) vs 275 (8.3%); propensity score-adjusted relative risk (RR) 1.10; 95% confidence interval (CI) 0.89-1.34; P=0.38], severe postoperative nausea and vomiting on day 1 [242 (7.3%) vs 189 (8.7%); propensity score-adjusted RR 1.06; 95% CI 0.86-1.30; P=0.59], quality of recovery score [median 14, interquartile range (IQR) 12-15, vs median 14, IQR 12-16, P=0.10), length of stay in the postanaesthesia care unit [propensity score-adjusted median (IQR) 2.0 (1.3, 2.9) vs 1.9 (1.3, 3.1), P=0.60], or the primary outcome of the main trial. Dexamethasone administration was associated with a decrease in fever on days 1-3 [182 (8.4%) vs 488 (14.7%); RR 0.61; 95% CI 0.5-0.74; P<0.001] and shorter lengths of stay in hospital [propensity score-adjusted median (IQR) 5.0 (2.9, 8.2) vs 5.3 (3.1, 9.1), P<0.001]. Neither diabetes mellitus nor surgical wound contamination status altered these outcomes. Conclusion. Dexamethasone administration to high-risk non-cardiac surgical patients did not increase the risk of postoperative wound infection or other adverse events up to day 30, and appears to be safe in patients either with or without diabetes mellitus. Clinical trial registration. NCT00430989.Copyright © 2017 The Author. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1093/bja/aew446 | Link to associated publication: | Click here for full text options | PubMed URL: | 28100522 [http://www.ncbi.nlm.nih.gov/pubmed/?term=28100522] | ISSN: | 0007-0912 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/38356 | Type: | Article | Subjects: | *infection risk *intraoperative period length of stay major clinical study male patient safety phase 2 clinical trial post hoc analysis postoperative nausea and vomiting/co [Complication] postoperative nausea and vomiting/dt [Drug Therapy] postoperative nausea and vomiting/pc [Prevention] priority journal probability propensity score randomized controlled trial recovery room *surgical infection/co [Complication] surgical patient *dexamethasone/ct [Clinical Trial] *dexamethasone/dt [Drug Therapy] fever adverse outcome aged anesthetic recovery article controlled study diabetes mellitus disease severity drug safety female heart surgery hospitalization human nitrous oxide female fever heart surgery hospitalization human *infection risk *intraoperative period length of stay major clinical study male patient safety phase 2 clinical trial post hoc analysis postoperative nausea and vomiting / complication / drug therapy / prevention priority journal probability propensity score recovery room *surgical infection / *complication surgical patient randomized controlled trial adverse outcome aged anesthetic recovery Article controlled study diabetes mellitus disease severity drug safety |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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