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Benzodiazepine-free Anesthetic for Reduction of Delirium (B-Free)

NCT03053869 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2018-10-16

No results posted yet for this study

Summary

The purpose of this two-centre pilot research study is to establish the feasibility of conducting a full trial that seeks to determine if a cardiac anesthesia policy that uses alternatives to benzodiazepine medications is better at preventing delirium after cardiac surgery when compared with a cardiac anesthesia policy that uses benzodiazepine medications.

Conditions

  • Post-operative Delirium

Interventions

DRUG

Benzodiazepine - limited use strategy

1. No routine use of any intraoperative benzodiazepines. 2. Accepted benzodiazepine use in the case of seizure, alcohol withdrawal, or known benzodiazepine dependence. 3. Accepted benzodiazepine use in patients who are hemodynamically unstable and/or have cardiac anatomy that puts them at high risk of developing ischemia on induction of anesthesia.

DRUG

Benzodiazepine - Ad libitum strategy

1. Administration of some benzodiazepine to most patients undergoing cardiac surgery. 2. Accepted lack of benzodiazepine use in patients who have contraindications to the administration of these medications (e.g. documented allergy).

Sponsors & Collaborators

Principal Investigators

  • Summer Syed, MD · McMaster University/Hamilton Health Sciences Corp.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03053869 on ClinicalTrials.gov