The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study
Tomas B Corcoran, Paul S Myles, Andrew B Forbes, Ed O'Loughlin, Kate Leslie, David Story, Timothy G Short, Matthew TV Chan, Pauline Coutts, Jaspreet Sidhu, Allen C Cheng, Leon A Bach, Kwok M Ho
BMJ OPEN | BMJ PUBLISHING GROUP | Published : 2019
INTRODUCTION: The intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications. METHODS/ANALYSIS: This is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre..View full abstract
Awarded by Australian NHMRC
Awarded by Research Grant Council, Hong Kong Special Administrative Region, China, General Research Fund
This work was supported by the Australian NHMRC, APP1079501, and the Research Grant Council, Hong Kong Special Administrative Region, China, General Research Fund, 14101816. Sponsor: Alfred Health, Melbourne, Victoria, Australia.