Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

Running, not enrolling · Not applicable

Conditions studied: Delirium, Post-cardiac Surgery

In brief

B-FREE is a pragmatic, multicentre, cluster crossover trial evaluating whether a policy limiting the use of intra-operative benzodiazepine reduces post-operative delirium when compared with a policy of 'ad libitum' administration. The knowledge generated by this study will provide the basis for cardiac anesthesia practice guidelines.

Key facts

Study ID

NCT03928236

Run by

Population Health Research Institute

People needed

15886

Starts

2019-11-18

Expected to finish

2025-04-30

Last updated by the study team

2025-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospital is a major surgical center with a minimum of 250 cases of cardiac surgery per year.
• Equipoise by the hospital physicians regarding the use of benzodiazepines during surgery (≥ 95% of hospital cardiac anesthesia group agrees to manage adult patients (age >18 years) as per the benzodiazepine policy in place during a given crossover period).
• Hospital routinely assesses patients (age >18 years) for postoperative delirium at least once every 12 hours during the initial 72 hours after cardiac surgery as a part of routine clinical care using either the Confusion Assessment Method-ICU (CAM-ICU) or the Intensive Care Delirium Screening Checklist (ICDSC).

You may not qualify if…

• Hospital does not meet inclusion criteria

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States
• Weill Cornell Medicine — New York, New York, United States
• Mazankowski Alberta Heart Institute — Edmonton, Alberta, Canada
• Royal Columbian Hospital — New Westminster, British Columbia, Canada
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• St. Boniface General Hospital — Winnipeg, Manitoba, Canada
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
• Hamilton Health Sciences, Hamilton General Hospital — Hamilton, Ontario, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Hôpital Laval — Québec, Quebec, Canada
• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada
• Regina General Hospital — Regina, Saskatchewan, Canada
• Royal University Hospital — Saskatoon, Saskatchewan, Canada

Full record on ClinicalTrials.gov

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