Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

NCT03928236 | Active Not Recruiting DMC

• 1 other identifier: B-Free.2019
• Study Type: interventional
• Target: 15,886
• Locations: 2 countries
• Sites: 20

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.

Conditions

Delirium; Post-cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of Delirium

  Delirium assessed up to 72 hours after surgery using standardized and validated delirium scales

  up to 72 hours post cardiac surgery

Secondary Outcomes (3)

• Number of Days in ICU after Cardiac Surgery

  through study completion, approximately 37 months

• Number of Days in Hospital after Cardiac Surgery

  through study completion, approximately 37 months

• Incidence of In-hospital Mortality

  through study completion, approximately 37 months

Study Arms (2)

Limited Benzodiazepine Policy

EXPERIMENTAL

Policy of no routine use of any intraoperative benzodiazepines.

Other: Limited Intraoperative Benzodiazepine

Liberal Benzodiazepine Policy

ACTIVE COMPARATOR

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.

Other: Liberal Intraoperative Benzodiazepine

Interventions

Limited Intraoperative Benzodiazepine OTHER

policy for limited use of intraoperative benzodiazepine

Limited Benzodiazepine Policy

Liberal Intraoperative Benzodiazepine OTHER

policy for liberal use of intraoperative benzodiazepine

Liberal Benzodiazepine Policy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (20)

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton Health Sciences, Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 4C6, Canada

Location

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N OW8, Canada

Location

Related Publications (3)

• Spence J, Devereaux PJ, Lee SF, D'Aragon F, Avidan MS, Whitlock RP, Mazer CD, Rousseau-Saine N, Rajamohan RR, Pryor KO, Klein R, Tan E, Cameron MJ, Di Sante E, DeBorba E, Mustard ME, Couture EJ, Zamper RPC, Law MWY, Djaiani G, Saha T, Choi S, Hedlin P, Pikaluk DR, Lam W, Deschamps A, Ramasundarahettige CF, Vincent J, McIntyre WF, Oczkowski SJW, Dulong BJ, Beaver C, Kloppenburg SA, Lamy A, Jacobsohn E, Belley-Cote EP; B-Free Investigators and the Canadian Perioperative Anesthesia Clinical Trials Group. Benzodiazepine-Free Cardiac Anesthesia for Reduction of Postoperative Delirium: A Cluster Randomized Crossover Trial. JAMA Surg. 2025 Mar 1;160(3):286-294. doi: 10.1001/jamasurg.2024.6602.

  PMID: 39878960 DERIVED

• Spence J, Belley-Cote E, Jacobsohn E, Lee SF, D'Aragon F, Avidan M, Mazer CD, Rousseau-Saine N, Rajamohan R, Pryor K, Klein R, Tan EC, Cameron M, Di Sante E, DeBorba E, Mustard M, Couture E, Zamper R, Law M, Djaiani G, Saha T, Choi S, Hedlin P, Pikaluk R, Lam WY, Deschamps A, Whitlock R, Dulong B, Devereaux PJ, Beaver C, Kloppenburg S, Oczkowski S, McIntyre WF, McFarling M, Lamy A, Vincent J, Connolly S; B-Free Investigators. Benzodiazepine-Free Cardiac Anesthesia for Reduction of Postoperative Delirium (B-Free): A Protocol for a Multi-centre Randomized Cluster Crossover Trial. CJC Open. 2023 Jun 8;5(9):691-699. doi: 10.1016/j.cjco.2023.06.001. eCollection 2023 Sep.

  PMID: 37744662 DERIVED

• Wang ML, Min J, Sands LP, Leung JM; the Perioperative Medicine Research Group. Midazolam Premedication Immediately Before Surgery Is Not Associated With Early Postoperative Delirium. Anesth Analg. 2021 Sep 1;133(3):765-771. doi: 10.1213/ANE.0000000000005482.

  PMID: 33721875 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jessica Spence, MD FRCPC

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Eric Jacobsohn, MBChB MPHE

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Stuart Connolly, MD FRCPC

  Population Health Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, cluster-randomized, crossover trial

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 26, 2019
• Study Start: November 18, 2019
• Primary Completion: December 11, 2022
• Study Completion: April 30, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (18)