An interventional study of Limited Intraoperative Benzodiazepine and Liberal Intraoperative Benzodiazepine in Delirium and Post-cardiac Surgery, sponsored by Population Health Research Institute. Active, not recruiting at 20 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Population Health Research Institute · Not applicable, Interventional, and Prevention
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.
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.
1,058 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 15,886 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Population Health Research Institute is the lead sponsor of 114 studies on the registry; 27 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Policy of no routine use of any intraoperative benzodiazepines.
Other: Limited Intraoperative Benzodiazepine
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.
Other: Liberal Intraoperative Benzodiazepine
policy for limited use of intraoperative benzodiazepine
policy for liberal use of intraoperative benzodiazepine
Incidence of Delirium
Delirium assessed up to 72 hours after surgery using standardized and validated delirium scales
Time frame: up to 72 hours post cardiac surgery
Number of Days in ICU after Cardiac Surgery
Length of Stay (LOS) in Intensive Care Unit after Cardiac Surgery
Time frame: through study completion, approximately 37 months
Number of Days in Hospital after Cardiac Surgery
Length of Stay (LOS) in Hospital after Cardiac Surgery
Time frame: through study completion, approximately 37 months
Incidence of In-hospital Mortality
Death from any cause after index cardiac surgery and during the index hospitalization
Time frame: through study completion, approximately 37 months
Plan to share: No
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Population Health Research Institute