Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

Delirium Clinical Trial

— B-Free  

Official title:

Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03928236
• Other study ID #: B-Free.2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: July 30, 2024

Study information

• Verified date: June 2024
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

B-FREE is a pragmatic, multicentre, cluster crossover trial evaluating whether a policy limiting the use of intra-operative benzodiazepine reduces post-operative delirium when compared with a policy of 'ad libitum' administration. The knowledge generated by this study will provide the basis for cardiac anesthesia practice guidelines.

Description:

Delirium, an acute state of confusion, occurs in approximately 1 in 5 adults after open heart surgery. Even though it is a temporary state, patients who experience delirium are at increased risk of serious problems that last after the delirium has resolved. These problems include decreases in thinking, mobility, self-care, and the ability to live independently in a community setting. Patients who experience delirium have longer stays in hospital, are more likely to be discharged to a nursing home, and are more likely to die. Benzodiazepines are a sedative and amnestic medication that may be associated with delirium. As such, benzodiazepines are rarely used for sedation in the intensive care unit after cardiac surgery. However, benzodiazepines continue to be used frequently in the operating room by anesthesiologists during open heart surgery because of their amnestic effects and limited impact on blood pressure. Nevertheless, practice is divided among cardiac anesthesiologists, with some never using benzodiazepines and others using them for nearly all patients.

Because the best approach (routine benzodiazepines or restricted benzodiazepines) remains uncertain, we will compare the effect of a hospital policy of intraoperative medication use that includes benzodiazepines to a policy that uses alternative medications and no benzodiazepines on the incidence of delirium after open heart surgery. The findings of the study have the potential to improve the outcomes of tens of thousands of patients around the world and will provide the basis for cardiac anesthesiology practice guidelines.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15886
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospital is a major surgical center with a minimum of 250 cases of cardiac surgery per year.

• Equipoise by the hospital physicians regarding the use of benzodiazepines during surgery (= 95% of hospital cardiac anesthesia group agrees to manage adult patients (age >18 years) as per the benzodiazepine policy in place during a given crossover period).

• Hospital routinely assesses patients (age >18 years) for postoperative delirium at least once every 12 hours during the initial 72 hours after cardiac surgery as a part of routine clinical care using either the Confusion Assessment Method-ICU (CAM-ICU) or the Intensive Care Delirium Screening Checklist (ICDSC).

Exclusion Criteria:

• Hospital does not meet inclusion criteria

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Post-cardiac Surgery

Intervention

Other:
• Limited Intraoperative Benzodiazepine
policy for limited use of intraoperative benzodiazepine
• Liberal Intraoperative Benzodiazepine
policy for liberal use of intraoperative benzodiazepine

Locations

Country	Name	City	State
Canada	Mazankowski Alberta Heart Institute	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences, Hamilton General Hospital	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Jewish General Hospital	Montréal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Hôpital Laval	Québec	Quebec
Canada	Regina General Hospital	Regina	Saskatchewan
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Weill Cornell Medicine	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Delirium	Delirium assessed up to 72 hours after surgery using standardized and validated delirium scales	up to 72 hours post cardiac surgery
Secondary	Number of Days in ICU after Cardiac Surgery	Length of Stay (LOS) in Intensive Care Unit after Cardiac Surgery	through study completion, approximately 37 months
Secondary	Number of Days in Hospital after Cardiac Surgery	Length of Stay (LOS) in Hospital after Cardiac Surgery	through study completion, approximately 37 months
Secondary	Incidence of In-hospital Mortality	Death from any cause after index cardiac surgery and during the index hospitalization	through study completion, approximately 37 months