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Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

NCT03928236 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15886

Last updated 2025-03-04

No results posted yet for this 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.

Conditions

  • Delirium
  • Post-cardiac Surgery

Interventions

OTHER

Limited Intraoperative Benzodiazepine

policy for limited use of intraoperative benzodiazepine

OTHER

Liberal Intraoperative Benzodiazepine

policy for liberal use of intraoperative benzodiazepine

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Jessica Spence, MD FRCPC · Population Health Research Institute

  • Eric Jacobsohn, MBChB MPHE · University of Manitoba

  • Stuart Connolly, MD FRCPC · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2022-12-11
Completion
2025-04-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928236 on ClinicalTrials.gov