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NCT Number: NCT03928236

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 cardiac anesthesia practice guidelines.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Limited Intraoperative Benzodiazepine

Other

policy for limited use of intraoperative benzodiazepine

Liberal Intraoperative Benzodiazepine

Other

policy for liberal use of intraoperative benzodiazepine

Primary outcomes

  1. Incidence of Delirium

    Time frame: up to 72 hours post cardiac surgery

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

Secondary outcomes

  1. Number of Days in ICU after Cardiac Surgery

    Time frame: through study completion, approximately 37 months

    Length of Stay (LOS) in Intensive Care Unit after Cardiac Surgery

  2. Number of Days in Hospital after Cardiac Surgery

    Time frame: through study completion, approximately 37 months

    Length of Stay (LOS) in Hospital after Cardiac Surgery

  3. Incidence of In-hospital Mortality

    Time frame: through study completion, approximately 37 months

    Death from any cause after index cardiac surgery and during the index hospitalization

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Acronym: B-Free

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Apr 26, 2019
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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