Dexamethasone and Surgical-Site Infection
Study Type: Randomised controlled trial
- 8 mg dexamethasone vs. placebo administered under GA
- International, multi-centre, triple-blind, non-inferiority trial against placebo
- 8,880 participants with modified intention-to-treat (mITT) analysis
- Inclusion: non-urgent, non-cardiac surgery of >2h, skin incision >5cm, and overnight or longer stay, ASA I-IV (those who did not meet inclusion criteria post-recruitment were excluded in the mITT analysis; any subsequent non-trial glucocorticoids were also excluded)
- Exclusion: pre-existing infection, HbA1C >9%, or surgical/medical indication for dexamethasone use.
- Primary outcome: Surgical site infection (SSI) within 30 days of surgery
- Non-inferiority of dexamethasone in mITT and per-protocol analyses
- Subgroup analyses of patients with diabetes mellitus also demonstrated non-inferiority of dexamethasone (note HbA1C >9% excluded)
- Secondary outcome analysis demonstrated slightly higher risk of chronic post-surgical pain at 6/12 with dexamethasone. Dexamethasone also seemed to be protective against acute post-op sepsis in the secondary outcome analyses.
- Methodologically and statistically valid and powerful results which should assure anaesthetic and surgical clinicians of the safety of intraoperative single-dose dexamethasone 8 mg in adults meeting the inclusion criteria when considering post-operative SSIs. Results are likely to be translatable to paediatric practice given mechanistic likeness. Clinicians are probably going to adopt results into paediatric practice. While this, scientifically, warrants specific investigation, equipoise will probably diminish with widespread adoption into practice.
- Several unanswered questions, some with higher clinical relevance are:
- Weight-based equivalence in paediatric practice to 8 mg in adults in terms of SSIs?
o Patients for emergency surgery?
o Patients with poorly controlled or severe DM?
o Is intraoperative single-dose dexamethasone associated with higher incidence of CPSP?
Reviewed by Dr Philip Cheung