NCT03053869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

February 13, 2017

Last Update Submit

October 15, 2018

Conditions

Post-operative Delirium

Outcome Measures

Primary Outcomes (3)

  • Confusion Assessment Method (CAM) assessment

    Completion of a minimum of at least 1 CAM assessment in 95% of patients - Outcome for larger, multi-centre trial

    1 day

  • Completion of a minimum of at least 1 CAM assessment per 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.

    1 day

  • Protocol adherence

    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.

    4-week crossover period

Secondary Outcomes (4)

  • Delirium duration

    5-7 days

  • Length of stay in the Intensive Care unit (ICU)

    1-3 days

  • Length of stay in Hospital

    5-14 days

  • In hospital mortality

    1-14 days

Study Arms (2)

Benzodiazepine - Limited use strategy

EXPERIMENTAL

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

Benzodiazepine - Ad libitum strategy

ACTIVE COMPARATOR

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

Interventions

Benzodiazepine - limited use strategyDRUG

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.

Also known as: Xanax, Valium, Ativan
Benzodiazepine - Limited use strategy
Benzodiazepine - Ad libitum strategyDRUG

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).

Also known as: Xanax, Valium, Ativan
Benzodiazepine - Ad libitum strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Location

Dr Summer Syed

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (5)

  • Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

    PMID: 23992774BACKGROUND

  • Marcantonio ER, Juarez G, Goldman L, Mangione CM, Ludwig LE, Lind L, Katz N, Cook EF, Orav EJ, Lee TH. The relationship of postoperative delirium with psychoactive medications. JAMA. 1994 Nov 16;272(19):1518-22.

    PMID: 7966844BACKGROUND

  • Gleason LJ, Schmitt EM, Kosar CM, Tabloski P, Saczynski JS, Robinson T, Cooper Z, Rogers SO Jr, Jones RN, Marcantonio ER, Inouye SK. Effect of Delirium and Other Major Complications on Outcomes After Elective Surgery in Older Adults. JAMA Surg. 2015 Dec;150(12):1134-40. doi: 10.1001/jamasurg.2015.2606.

    PMID: 26352694BACKGROUND

  • Spence J, Belley-Cote E, Jacobsohn E, Lee SF, Whitlock R, Bangdiwala S, Syed S, Sarkaria A, MacIsaac S, Lengyel A, Long S, Um K, McIntyre WF, Kavosh M, Fast I, Arora R, Lamy A, Connolly S, Devereaux PJ. Restricted versus liberal intraoperative benzodiazepine use in cardiac anaesthesia for reducing delirium (B-Free Pilot): a pilot, multicentre, randomised, cluster crossover trial. Br J Anaesth. 2020 Jul;125(1):38-46. doi: 10.1016/j.bja.2020.03.030. Epub 2020 May 13.

    PMID: 32416996DERIVED

  • Spence J, Belley-Cote E, Lee SF, Bangdiwala S, Whitlock R, LeManach Y, Syed S, Lamy A, Jacobsohn E, MacIsaac S, Devereaux PJ, Connolly S. The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial. Can J Anaesth. 2018 Jul;65(7):813-821. doi: 10.1007/s12630-018-1130-2. Epub 2018 Apr 18.

    PMID: 29671186DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

AlprazolamDiazepamLorazepam

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzodiazepinones

Study Officials

  • Summer Syed, MD

    McMaster University/Hamilton Health Sciences Corp.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 15, 2017

Study Start

April 1, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

CA(2)