Benzodiazepine-Free Cardiac Anesthesia for Reduction of Delirium in the Intensive Care Unit (B-Free): A Two-Centre Pilot Study to Determine the Feasibility of a Multi-Centre, Randomized, Cluster Crossover Trial
CCCF ePoster library. Spence J. Nov 8, 2018; 233343
Dr. Jessica Spence
Dr. Jessica Spence
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Abstract
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Introduction: Postoperative delirium affects 15-30% of adult cardiac surgery patients and is associated with adverse outcomes. Intensive care unit (ICU) data suggest that benzodiazepines are linked to delirium. Guidelines issued by the American Geriatric Society and American College of Critical Care Medicine recommend minimizing their use. While the benefit of alternate forms of sedation after cardiac surgery have been studied, no trials have examined the impact of changes to intraoperative benzodiazepine use.

Objective: We sought to determine the feasibility of a multicentre, randomized cluster crossover trial evaluating whether an institutional policy of limited intraoperative benzodiazepine administration (B-Free) during adult cardiac surgery was associated with a decrease in the incidence of postoperative delirium, when compared with a policy of ‘ad libitum’ intraoperative benzodiazepine administration.

Methods: We conducted a two-centre, pilot randomized cluster crossover trial with four-four-week crossover periods. We obtained research ethics board approval for waiver of individual patient consent in both sites; all patients undergoing cardiac surgery during the pilot period were studied. Each site was randomized to either the B-Free or ad libitum policy and then alternated between intervention arms during the remaining 3 crossover periods. Our feasibility outcomes were: 1) obtaining at least one postoperative Confusion Assessment Method (CAM) delirium evaluation in 95% of enrolled patients, 2) obtaining at least one CAM per 24h in the ICU in 90% of enrolled patients, and 3) to achieve adherence to each of the intervention arm policies in 80% of patients. In a single site, we evaluated the incidence of intraoperative awareness using serial Brice questionnaires and blinded adjudication, aiming to demonstrate an incidence of intraoperative awareness during the limited benzodiazepine period of no more than 2%.

Results: We studied 800 patients, of which 362/388 (93.3%) of patients managed during the ad libitum periods and 365/412 (88.6%) of patients managed during the B-Free periods were managed according to the appropriate policy. 770/800 (96.3%) had at least one CAM, and 739/800 (92.4%) had at least one CAM per 24h in ICU. We screened 521/540 (96.5%) enrolled patients at one site for intraoperative awareness; 19/540 (3.5%) of patients were not screened because of intraoperative death, transfer or death prior to extubation, or communication barrier. 1/521 (0.2%), managed during the B-Free period but who received benzodiazepine, was adjudicated as having awareness.

Conclusion: Data obtained demonstrates the feasibility of conducting a multi-centre, randomized, cluster crossover trial evaluating whether an institutional policy of limited intraoperative benzodiazepine use during adult cardiac surgery is associated with a decrease in the incidence of postoperative delirium, when compared with a policy of ‘ad libitum’ intraoperative benzodiazepine use.


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