1. This phase III drug trial showed that dexamethasone does not significantly reduce risk of adverse events and death following major non-cardiac surgery.
2. Secondary safety outcomes were comparable between the dexamethasone and placebo groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Major surgery has potential major complications, such as shock, infection, bleeding, and clots. The complex inflammatory response post-surgery may be a risk factor for adverse events if left to mount unchecked. Dexamethasone, a glucocorticoid, has been shown to reduce systemic inflammation in cases of septic shock and trauma, and could be potentially beneficial postoperatively. In this French randomized control trial, 1184 patients undergoing major non-cardiac surgery were given either placebo or dexamethasone postoperatively and followed for death or adverse events. After 14 days, results showed no significant different in risk of adverse events or mortality between the two treatment groups. Additionally, secondary safety outcomes such as wound healing did not differ. Limitations of this study included the short follow-up period post-surgery. Patients were also not stratified on case severity which could have influenced outcomes. Nonetheless, this is a high-quality phase III drug trial which will inform clinical decision making.
Click to read the study in the BMJ
Relevant Reading: Dexamethasone in Hospitalized Patients with Covid-19
In-Depth [randomized controlled trial]: This study took place in 34 different medical centers from December 2017 to March 2019. 1222 adults undergoing major non-cardiac surgery were recruited. Ultimately, 1184 patients were randomized to receive either dexamethasone (n = 595) or placebo (n = 589), stratified by criteria of cancer or thoracic procedure. The primary outcome was postoperative complications and all-cause mortality within fourteen days after surgery. Overall, 17% of the dexamethasone group versus 19.9% in the placebo group had died or developed complications 14-days post-surgery (adjusted odds ratio 0.81, 95% CI 0.60-1.08; P=0.15). The rate of adverse events did not differ between groups with 47% of the dexamethasone and 48.6% of the placebo group reporting adverse events (P=0.46). However, the need for mechanical ventilation for postoperative respiratory failure was reduced in those receiving dexamethasone (6.9% in the dexamethasone group vs. 8.8% in the placebo group; P=0.015). Overall, study results suggest that dexamethasone cannot currently be recommended for the reduction of postoperative complications and mortality in patients undergoing major non-cardiac surgeries.
Image: PD
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