Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium
- Conditions
- Post-cardiac SurgeryDelirium
- Interventions
- Other: Liberal Intraoperative BenzodiazepineOther: Limited Intraoperative Benzodiazepine
- Registration Number
- NCT03928236
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
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.
- Detailed Description
Delirium, an acute state of confusion, occurs in approximately 1 in 5 adults after open heart surgery. Even though it is a temporary state, patients who experience delirium are at increased risk of serious problems that last after the delirium has resolved. These problems include decreases in thinking, mobility, self-care, and the ability to live independently in a community setting. Patients who experience delirium have longer stays in hospital, are more likely to be discharged to a nursing home, and are more likely to die. Benzodiazepines are a sedative and amnestic medication that may be associated with delirium. As such, benzodiazepines are rarely used for sedation in the intensive care unit after cardiac surgery. However, benzodiazepines continue to be used frequently in the operating room by anesthesiologists during open heart surgery because of their amnestic effects and limited impact on blood pressure. Nevertheless, practice is divided among cardiac anesthesiologists, with some never using benzodiazepines and others using them for nearly all patients.
Because the best approach (routine benzodiazepines or restricted benzodiazepines) remains uncertain, we will compare the effect of a hospital policy of intraoperative medication use that includes benzodiazepines to a policy that uses alternative medications and no benzodiazepines on the incidence of delirium after open heart surgery. The findings of the study have the potential to improve the outcomes of tens of thousands of patients around the world and will provide the basis for cardiac anesthesiology practice guidelines.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15886
- 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).
- Hospital does not meet inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Liberal Benzodiazepine Policy Liberal Intraoperative Benzodiazepine Policy for the administration of benzodiazepine as per clinical guidelines but no lower than 0.03 mg/kg (ideal body weight midazolam equivalent) to all patients undergoing cardiac surgery. Any benzodiazepine may be used. Limited Benzodiazepine Policy Limited Intraoperative Benzodiazepine Policy of no routine use of any intraoperative benzodiazepines.
- Primary Outcome Measures
Name Time Method Incidence of Delirium up to 72 hours post cardiac surgery Delirium assessed up to 72 hours after surgery using standardized and validated delirium scales
- Secondary Outcome Measures
Name Time Method Number of Days in ICU after Cardiac Surgery through study completion, approximately 37 months Length of Stay (LOS) in Intensive Care Unit after Cardiac Surgery
Number of Days in Hospital after Cardiac Surgery through study completion, approximately 37 months Length of Stay (LOS) in Hospital after Cardiac Surgery
Incidence of In-hospital Mortality through study completion, approximately 37 months Death from any cause after index cardiac surgery and during the index hospitalization
Trial Locations
- Locations (20)
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
🇨🇦Montréal, Quebec, Canada
Jewish General Hospital
🇨🇦Montréal, 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