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Active, not recruitingNo phase

Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

Key facts

Who runs it
Population Health Research Institute
Where
New York and St Louis, United StatesSee the 2 sitesAlso in 1 other country, 18 sites
Trial code
Status
Active, not recruiting
People taking part
15,886 people, planned
Started
18 Nov 2019
Ended
30 Apr 2025
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Limited Intraoperative Benzodiazepine
  • Liberal Intraoperative Benzodiazepine
Record updated
4 March 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Hospital does not meet inclusion criteria

Where in United States

Also in 1 other country, 18 sites

  • Weill Cornell MedicineNew York, United States
  • Washington University School of MedicineSt Louis, United States

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Limited Benzodiazepine PolicyTreatment being tested

    Policy of no routine use of any intraoperative benzodiazepines.

    Treatment: Limited Intraoperative Benzodiazepine

  • Liberal Benzodiazepine PolicyExisting treatment, for comparison

    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.

    Treatment: Liberal Intraoperative Benzodiazepine

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Publications
Record updated
4 March 2025