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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03053869
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University

Brief 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.

Condition or disease Intervention/treatment Phase
Post-operative Delirium Drug: Benzodiazepine - limited use strategy Drug: Benzodiazepine - Ad libitum strategy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Benzodiazepine-free Anesthetic for Reduction of Delirium (B-Free): A Two-centre Pilot Study to Determine the Feasibility of a Multi-centre, Randomized, Cluster Crossover Trial
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: 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 - 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.
Other Name: Xanax, Valium, Ativan

Active Comparator: 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).
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).
Other Name: Xanax, Valium, Ativan




Primary Outcome Measures :
  1. Confusion Assessment Method (CAM) assessment [ Time Frame: 1 day ]
    Completion of a minimum of at least 1 CAM assessment in 95% of patients - Outcome for larger, multi-centre trial

  2. Completion of a minimum of at least 1 CAM assessment per day [ Time Frame: 1 day ]
    Completion of a minimum of at least 1 CAM assessment per day in ICU in 90% of patients, and completion of at least a single CAM assessment in 95% of all patients treated during the study period. Given our sample size of 480 patients, this would constitute completion of a single CAM assessment in 456/480 patients. CAM assessments are completed and documented in the electronic medical record by both ICU and ward nurses a minimum of every 12 hours (and more frequently in patients with delirium) in all cardiac surgery patients as part of routine patient care. - Feasibility outcome of pilot.

  3. Protocol adherence [ Time Frame: 4-week crossover period ]
    Protocol compliance by individual practitioners such that 80% of patients are not administered any intraoperative benzodiazepines during the benzodiazepine minimization period, and 80% of patients receive intraoperative benzodiazepines during the ad libitum benzodiazepine period.


Secondary Outcome Measures :
  1. Delirium duration [ Time Frame: 5-7 days ]
    Total number of CAM positive days while in hospital - Outcome for larger, multi-centre trial

  2. Length of stay in the Intensive Care unit (ICU) [ Time Frame: 1-3 days ]
    Total number of days in the ICU - Outcome for larger, multi-centre trial

  3. Length of stay in Hospital [ Time Frame: 5-14 days ]
    Total number of days in the hospital - Outcome for larger, multi-centre trial

  4. In hospital mortality [ Time Frame: 1-14 days ]
    Death in hospital - Outcome for larger, multi-centre trial



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing cardiac surgery during the study period at the Hamilton General and St. Boniface General Hospitals.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053869


Locations
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Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Canada, Ontario
Dr Summer Syed
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Summer Syed, MD McMaster University/Hamilton Health Sciences Corp.
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03053869    
Other Study ID Numbers: 2159
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Diazepam
Lorazepam
Alprazolam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscle Relaxants, Central
Neuromuscular Agents
Anesthetics, Intravenous
Anesthetics, General