What side effects are associated with this type of intervention?

Common treatments for delirium, particularly those involving benzodiazepines, are associated with side effects such as cognitive impairment, increased risk of falls, dependence, withdrawal symptoms, and potential rebound anxiety. In older adults, long-term use of benzodiazepines has been linked to an elevated risk of dementia. Non-benzodiazepine treatments like melatonin and melatonin receptor agonists, which are sometimes used to manage sleep disturbances in delirium, generally have milder side effects but can still cause dizziness and daytime drowsiness.

What prior FDA approvals exist?

There are no specific FDA-approved medications for the treatment of delirium that focus on reducing GABA-A receptor activation. The trial mentioned, which limits intra-operative benzodiazepine use, aims to reduce postoperative delirium by minimizing GABA-A receptor activation. Benzodiazepines, which enhance GABA-A receptor activity, are generally avoided in delirium management due to their potential to exacerbate symptoms. Current management strategies for delirium often involve non-pharmacologic approaches and, when necessary, the use of antipsychotics like haloperidol or atypical antipsychotics, although these are not FDA-approved specifically for delirium.

What other types of research exist?

Promising alternatives to limiting intra-operative benzodiazepine use for reducing delirium include the use of gabapentinoids (gabapentin, pregabalin) for their analgesic and anxiolytic properties, melatonin for its sedative and anxiolytic effects, and non-pharmacological approaches such as cognitive treatments and relaxation techniques.

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Other

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

Summary

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Delirium

Secondary study objectives

Incidence of In-hospital Mortality

Number of Days in Hospital after Cardiac Surgery

Number of Days in ICU after Cardiac Surgery

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Delirium treatments often target neurotransmitter imbalances, particularly those involving the GABAergic and cholinergic systems. Benzodiazepines, which enhance GABA-A receptor activation, can exacerbate delirium by increasing inhibitory neurotransmission, leading to cognitive impairment. Therefore, limiting intra-operative benzodiazepine use, as studied in the B-FREE trial, aims to reduce this risk. Alternative treatments, such as antipsychotics, work by modulating dopamine and serotonin receptors, helping to restore neurotransmitter balance and improve cognitive function. Understanding these mechanisms is crucial for optimizing delirium management and minimizing adverse effects.

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Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

161 Previous Clinical Trials

696,248 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

~2723 spots leftby Sep 2025

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