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ACTIVE NOT RECRUITING NA

Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

NCT03928236 · View on ClinicalTrials.gov ↗

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.

Interventions

  • OTHER Limited Intraoperative Benzodiazepine
  • OTHER Liberal Intraoperative Benzodiazepine

Study Locations (20)

Ontario

  • Hamilton Health Sciences, Hamilton General Hospital — Hamilton
  • Kingston General Hospital — Kingston
  • London Health Sciences Centre — London
  • Sunnybrook Health Sciences Centre — Toronto
  • St. Michael's Hospital — Toronto
  • Toronto General Hospital — Toronto

Quebec

  • Montreal Heart Institute — Montreal
  • Jewish General Hospital — Montreal
  • Hôpital Laval — Québec
  • Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke

British Columbia

  • Royal Columbian Hospital — New Westminster
  • Vancouver General Hospital — Vancouver
  • St. Paul's Hospital — Vancouver

Saskatchewan

  • Regina General Hospital — Regina
  • Royal University Hospital — Saskatoon

Missouri

  • Washington University School of Medicine — St Louis

New York

  • Weill Cornell Medicine — New York

Alberta

  • Mazankowski Alberta Heart Institute — Edmonton

Manitoba

  • St. Boniface General Hospital — Winnipeg

Trial Details

FieldValue
Enrollment Target 15,886 participants
Start Date 2019-11-18
Est. Completion 2025-04-30
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03928236

The ClinicalTrials.gov registry entry for NCT03928236 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15,886 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Population Health Research Institute, which has 68 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Delirium appearing as the primary indexed condition, and to 2 interventions — of which Limited Intraoperative Benzodiazepine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03928236 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Ontario, Quebec, British Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03928236 about?

NCT03928236 is a clinical study titled "Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium". 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 card...

What is the current status of trial NCT03928236?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 15,886 participants. The study started on 2019-11-18. Estimated completion is 2025-04-30.

What conditions does trial NCT03928236 study?

This clinical trial studies the following conditions: Delirium, Post-cardiac Surgery. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03928236?

The interventions under investigation include: Limited Intraoperative Benzodiazepine (OTHER), Liberal Intraoperative Benzodiazepine (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03928236?

This trial is sponsored by Population Health Research Institute, which has 68 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03928236 being conducted?

This trial has 20 study locations across Missouri, New York, Alberta, British Columbia, Manitoba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial