Perioperative ADministration of Dexamethasone and Infection Trial
Every year millions of patients undergo surgery worldwide. Surgical site infections (SSI) occur in up to 12 per cent of these patients. Complications resulting from SSI lead to increased morbidity and mortality, extended hospital stays, and carry an associated cost of up to US$10 billion per annum.
Dexamethasone is widely used by anaesthetists in the perioperative period, principally as an effective antiemetic to prevent postoperative nausea and vomiting (PONV). The molecular mechanisms underlying dexamethasone’s antiemetic action are not fully understood. However, because it is a potent glucocorticosteroid, it is has immunosuppressive and hyperglycaemia effects. It is hypothesised that these actions may increase the risk of perioperative infections, particularly in patients with diabetes mellitus, who are already at increased risk of complications. Whether the use of dexamethasone in the perioperative period increases the risk of surgical site and other infections, has not been definitively established. This is an important health priority as in Australia alone up to one million patients will receive dexamethasone as part of their anaesthesia care annually.
This study aims to definitively address the impact of dexamethasone on surgical site infection and will be stratified according to diabetes status.
8880 adult patients
Multi-centre prospective, double blind, active control, parallel assessment, stratified, pragmatic non-inferiority safety and efficacy study.
Surgical site infection within 30 days of surgery.
Secondary outcomes include nausea and vomiting parameters, quality of perioperative analgesia, the incidence of chronic postsurgical pain, length of hospital stay, quality of recovery on days 1 and 30, inflammatory responses, glucose-related outcomes, infections at site other than the surgical site (pneumonia, bloodstream infection, urinary tract infection) up to 30 days, the incidence of sepsis and the incidence of wound dehiscence.
Adult patients, ASA physical status 1-4, undergoing elective or expedited (non-cardiac) surgery of at least two hours duration, using general anaesthesia with or without regional block, with a single (or multiple) surgical skin incision(s) of >5 cm in length, and a minimum anticipated hospital stay of at least one night.
This study is now closed. Results will be published in 2020.