Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

Conditions

Delirium, Post-cardiac Surgery

Brief 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.

Detailed 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.

Spence J, Devereaux PJ, Lee SF, D'Aragon F, Avidan MS, Whitlock RP, Mazer CD, Rousseau-Saine N, Rajamohan RR, Pryor KO, Klein R, Tan E, Cameron MJ, Di Sante E, DeBorba E, Mustard ME, Couture EJ, Zamper RPC, Law MWY, Djaiani G, Saha T, Choi S, Hedlin P, Pikaluk DR, Lam W, Deschamps A, Ramasundarahettige CF, Vincent J, McIntyre WF, Oczkowski SJW, Dulong BJ, Beaver C, Kloppenburg SA, Lamy A, Jacobsohn E, Belley-Côté EP, B-Free Investigators and the Canadian Perioperative Anesthesia Clinical Trials Group.

2025-03-019 citations

10.1001/jamasurg.2024.6602

Benzodiazepine-Free Cardiac Anesthesia for Reduction of Postoperative Delirium (B-Free): A Protocol for a Multi-centre Randomized Cluster Crossover Trial.

Spence J, Belley-Côté E, Jacobsohn E, Lee SF, D'Aragon F, Avidan M, Mazer CD, Rousseau-Saine N, Rajamohan R, Pryor K, Klein R, Tan EC, Cameron M, Di Sante E, DeBorba E, Mustard M, Couture E, Zamper R, Law M, Djaiani G, Saha T, Choi S, Hedlin P, Pikaluk R, Lam WY, Deschamps A, Whitlock R, Dulong B, Devereaux PJ, Beaver C, Kloppenburg S, Oczkowski S, McIntyre WF, McFarling M, Lamy A, Vincent J, Connolly S, B-Free Investigators.

2023-06-088 citations

10.1016/j.cjco.2023.06.001

Tranexamic acid for the prevention of postpartum haemorrhage: the TAPPH-1 pilot randomized trial and lessons learned for trials in Canadian obstetrics

Asim Alam, Jon Barrett, Jeannie Callum, Lilia Kaustov, Shelly Au et al. (8 authors)

Scientific Reports2023-03-185 citations

10.1038/s41598-023-30947-8

Interventions

OTHERLimited Intraoperative Benzodiazepine

policy for limited use of intraoperative benzodiazepine

OTHERLiberal Intraoperative Benzodiazepine

policy for liberal use of intraoperative benzodiazepine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Multicenter, cluster-randomized, crossover trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Delirium	up to 72 hours post cardiac surgery	Delirium assessed up to 72 hours after surgery using standardized and validated delirium scales

Secondary

Measure	Time frame	Description
Number of Days in ICU after Cardiac Surgery	through study completion, approximately 37 months	Length of Stay (LOS) in Intensive Care Unit after Cardiac Surgery
Number of Days in Hospital after Cardiac Surgery	through study completion, approximately 37 months	Length of Stay (LOS) in Hospital after Cardiac Surgery
Incidence of In-hospital Mortality	through study completion, approximately 37 months	Death from any cause after index cardiac surgery and during the index hospitalization

Countries

Canada, United States

Outcome results

None listed