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Benzodiazepine Use During Cardiac Surgery for Postoperative Delirium (B-Free Trial)

N/A

Waitlist Available

Led By Jessica Spence, MD FRCPC

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 37 months

Awards & highlights

B-Free Trial Summary

This trial will compare two policies for using the drug benzodiazepine during surgery, to see if one policy leads to less post-operative delirium than the other. The results of the trial will be used to create guidelines for how to use this drug during surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include differences in sedation levels, withdrawal symptoms, or changes in risk of postoperative delirium depending on the amount of benzodiazepine administered.

B-Free Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 37 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 37 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 37 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Delirium

Secondary outcome measures

Incidence of In-hospital Mortality

Number of Days in Hospital after Cardiac Surgery

Number of Days in ICU after Cardiac Surgery

B-Free Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Limited Benzodiazepine PolicyExperimental Treatment1 Intervention

Policy of no routine use of any intraoperative benzodiazepines.

Group II: Liberal Benzodiazepine PolicyActive Control1 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

664,026 Total Patients Enrolled

Jessica Spence, MD FRCPCPrincipal InvestigatorPopulation Health Research Institute

Eric Jacobsohn, MBChB MPHEPrincipal InvestigatorUniversity of Manitoba

Media Library

Benzodiazepine-free Cardiac Anesthesia (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03928236 — N/A

Delirium Research Study Groups: Liberal Benzodiazepine Policy, Limited Benzodiazepine Policy

Delirium Clinical Trial 2023: Benzodiazepine-free Cardiac Anesthesia Highlights & Side Effects. Trial Name: NCT03928236 — N/A

Benzodiazepine-free Cardiac Anesthesia (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03928236 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of subjects taking part in this clinical experiment?

"Indeed, according to clinicaltrials.gov, this medical investigation is presently enrolling patients. It was initially posted on November 18th 2019 and the most recent update was registered on October 11th 2022. The study requires 15886 participants from a single site in order to be completed successfully."

Answered by AI

Is this research project currently accepting participants?

"As per the records on clinicaltrials.gov, this trial is still awaiting participants. It was first listed back in November 2019 and its latest update was registered in October 2022."

Answered by AI

Recent research and studies

Anesthesia & AnalgesiaJournal

Midazolam Premedication Immediately Before Surgery Is Not Associated with Early Postoperative Delirium

Wang, Man-Ling, Jie Min, Laura P. Sands, Jacqueline M. Leung, and the Perioperative Medicine Research Group. 2021. “Midazolam Premedication Immediately Before Surgery Is Not Associated with Early Postoperative Delirium”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000005482.

clinicaltrials.govStudy

Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

2019. "Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03928236.

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