Benzodiazepine Use During Cardiac Surgery for Postoperative Delirium

(B-Free Trial)

Not currently recruiting at 24 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether limiting benzodiazepines (a type of sedative) during heart surgery can reduce the risk of postoperative confusion or delirium. Researchers will compare two approaches: one using benzodiazepines freely and another using benzodiazepine-free cardiac anesthesia. The goal is to determine if avoiding these sedatives can prevent postoperative delirium, which can cause confusion and memory issues. Individuals who have experienced delirium or confusion after heart surgery might find the outcomes particularly relevant. As an unphased trial, this study allows patients to contribute to important research that could enhance postoperative care for future heart surgery patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for cardiac surgery patients?

Research has shown that using fewer benzodiazepines during heart surgery might reduce the risk of post-surgery confusion, known as delirium. Benzodiazepines calm patients or help them sleep. However, studies have found that patients receiving these drugs in the ICU after heart surgery may have a higher likelihood of experiencing delirium.

Benzodiazepine-free cardiac anesthesia aims to avoid these drugs during surgery unless absolutely necessary. Researchers are testing this approach to determine if it can lower the chances of delirium after surgery.

While studies highlight the potential benefits of using fewer benzodiazepines, patient safety remains a priority. So far, no clear evidence indicates major safety concerns with reducing benzodiazepine use during surgery. This suggests that limiting these drugs might be safe, but more research is needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether limiting or eliminating benzodiazepine use during cardiac surgery can reduce the risk of postoperative delirium. While benzodiazepines are commonly used for sedation, they may contribute to delirium, a condition that can complicate recovery. By comparing a liberal benzodiazepine policy with a limited one, researchers hope to find out if a benzodiazepine-free approach improves patient outcomes, potentially leading to a shift in anesthesia practices for cardiac surgery.

What evidence suggests that this trial's treatments could be effective for reducing postoperative delirium?

This trial will compare two approaches to benzodiazepine use during cardiac surgery. In one arm, participants will follow a Liberal Benzodiazepine Policy, where benzodiazepines are administered according to clinical guidelines. In the other arm, participants will follow a Limited Benzodiazepine Policy, with no routine use of intraoperative benzodiazepines. Research has shown that avoiding benzodiazepines during heart surgery might not significantly reduce the risk of postoperative delirium. Studies have found that even with reduced benzodiazepine use, the delirium rate remains similar to when these drugs are used more frequently. However, benzodiazepines are generally linked to delirium, especially in intensive care settings, leading some guidelines to recommend their reduced use. While evidence for reducing delirium in heart surgery by avoiding benzodiazepines is not strong, the wider medical community advises caution with these drugs due to their potential side effects. ^{1 2 4 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2829514

Benzodiazepine-Free Cardiac Anesthesia for Reduction of ... A landmark pragmatic study exploring whether institutional restrictions on intraoperative benzodiazepines reduce postoperative delirium after cardiac surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11780505/

Benzodiazepine-Free Cardiac Anesthesia for Reduction of ... In intention-to-treat analyses, restricting benzodiazepines during cardiac surgery did not reduce delirium incidence but was also not associated with an ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X23001270

Benzodiazepine-Free Cardiac Anesthesia for Reduction of ... The primary outcome is the incidence of delirium at up to 72 hours after surgery. The B-Free trial will enroll ≥ 18,000 patients undergoing cardiac surgery at ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03053869

Benzodiazepine-free Anesthetic for Reduction of Delirium ... ICU data suggests that benzodiazepines are linked to delirium, and minimizing their use has been incorporated into ICU practice guidelines. Cardiac surgery ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39878960/

Benzodiazepine-Free Cardiac Anesthesia for Reduction of ... Conclusions and relevance: In intention-to-treat analyses, restricting benzodiazepines during cardiac surgery did not reduce delirium incidence ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/study/NCT03928236

Benzodiazepine-free Cardiac Anesthesia for Reduction of ... B-FREE is a pragmatic, multicentre, cluster crossover trial evaluating whether a policy limiting the use of intra-operative benzodiazepine reduces ...

7. jcvaonline.com jcvaonline.com/article/S1053-0770(25)00249-6/fulltext

Does Benzodiazepine-Free Cardiac Anesthesia Reduce ... Post hoc analyses suggest that restricting benzodiazepines might reduce the number of assessments documenting the presence of delirium, ...