Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

NCT03928236 · tracked via the Priya Life Science Canada tracker

Sponsor

Population Health Research Institute

Phase

Not applicable

Started

2019-11-18

Last updated

2025-03-04

Condition(s) studied

DeliriumPost-cardiac Surgery

Investigational drug(s) / intervention(s)

Limited Intraoperative BenzodiazepineLiberal Intraoperative Benzodiazepine

Limited Intraoperative Benzodiazepine: policy for limited use of intraoperative benzodiazepine

Liberal Intraoperative Benzodiazepine: policy for liberal use of intraoperative benzodiazepine

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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). Exclusion Criteria: \- Hospital does not meet inclusion criteria

Primary outcome measure(s)

Incidence of Delirium — up to 72 hours post cardiac surgery
Delirium assessed up to 72 hours after surgery using standardized and validated delirium scales

Trial sites (20)

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

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Other trials for the same condition

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Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients Recruiting

Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury Recruiting

Melatonin for Treatment of Delirium in Critically Ill Adult Patients Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03928236 on ClinicalTrials.gov ↗ ← All trials in Canada