Benzodiazepine Use During Cardiac Surgery for Postoperative Delirium

(B-Free Trial)

Recruiting at 21 trial locations

Overseen By B-Free Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Population Health Research Institute

Disqualifiers: Hospital not meeting criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

15886 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if using less of a sedative drug during heart surgery can reduce confusion afterward. It focuses on adults having open heart surgery, as many experience confusion post-surgery. The study aims to see if reducing this drug can prevent such confusion.

Research Team

Jessica Spence, MD FRCPC

Principal Investigator

Population Health Research Institute

Eric Jacobsohn, MBChB MPHE

Principal Investigator

University of Manitoba

Stuart Connolly, MD FRCPC

Principal Investigator

Population Health Research Institute

Eligibility Criteria

This trial is for adults over 18 years old who are undergoing cardiac surgery at hospitals performing at least 250 such surgeries a year. These hospitals must also routinely check patients for postoperative delirium using standard methods and agree to follow the study's benzodiazepine use policy.

Inclusion Criteria

My hospital checks for confusion after heart surgery using specific methods.

My hospital performs over 250 heart surgeries a year.

My hospital's cardiac anesthesia team agrees on using benzodiazepines during surgery as per their policy.

Exclusion Criteria

Hospital does not meet inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery with either a liberal or limited benzodiazepine policy

1 week

In-hospital stay for surgery

Follow-up

Participants are monitored for incidence of delirium and other outcomes post-surgery

72 hours

In-hospital monitoring

Extended Follow-up

Participants' length of stay in ICU and hospital is monitored, along with in-hospital mortality

up to 37 months

Treatment Details

Interventions

• Benzodiazepine-free Cardiac Anesthesia

Trial Overview The B-FREE trial is testing if limiting benzodiazepines during heart surgery can reduce cases of confusion or delirium after the operation, compared to when these drugs are used without restriction. Hospitals will switch policies in different periods to compare results.

Participant Groups

Group I: Limited Benzodiazepine Policy Experimental Treatment 1 Intervention

Policy of no routine use of any intraoperative benzodiazepines.

Group II: Liberal Benzodiazepine Policy Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+