B-Free
Trial question
What is the effect of a restrictive benzodiazepine policy on patients undergoing open cardiac surgery?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 19768
19768 patients (5240 female, 14528 male).
Inclusion criteria: adult patients undergoing open cardiac surgery.
Key exclusion criteria: percutaneous procedures and secondary operations during the same admission; inconsistent assessment of delirium; inadequate research hospital infrastructure.
Interventions
N=9827 restrictive benzodiazepine policy (restriction of benzodiazepine as part of cardiac anesthesia).
N=9941 liberal benzodiazepine policy (receipt of ≥ 0.03 mg/kg ideal body weight of midazolam equivalent for cardiac anesthesia).
Primary outcome
Delirium up to 72 hours after cardiac surgery
14%
14.9%
14.9 %
11.2 %
7.5 %
3.7 %
0.0 %
Restrictive benzodiazepine
policy
Liberal benzodiazepine
policy
No significant
difference ↔
No significant difference in delirium up to 72 hours after cardiac surgery (14% vs. 14.9%; OR 0.92, 95% CI 0.84 to 1.01).
Secondary outcomes
No significant difference in least squares mean intensive care length of stay (3.5 days vs. 3.5 days; MD 0.04, 95% CI -0.12 to 0.27).
No significant difference in least squares mean hospital length of stay (12.6 days vs. 12.7 days; MD -0.05, 95% CI -0.53 to 0.31).
No significant difference in death in the hospital (3% vs. 2.7%; OR 1.13, 95% CI 0.95 to 1.34).
Safety outcomes
No significant difference in patient-reported intraoperative awareness.
Conclusion
In adult patients undergoing open cardiac surgery, restrictive benzodiazepine policy was not superior to liberal benzodiazepine policy with respect to delirium up to 72 hours after cardiac surgery.
Reference
Jessica Spence, P J Devereaux, Shun-Fu Lee et al. Benzodiazepine-Free Cardiac Anesthesia for Reduction of Postoperative Delirium: A Cluster Randomized Crossover Trial. JAMA Surg. 2025 Jan 29:e246602. Online ahead of print.
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