drugset / Trial / NCT03053869
Benzodiazepine-free Anesthetic for Reduction of Delirium (B-Free)
RandomizedCrossoverOpen-labelPrevention
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.
Timeline
- Start
- 2017-04-01
- Primary completion
- 2018-09-30
- Completion
- 2018-09-30
Publications
- Background 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.
- Background 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.
- Background 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alprazolam | Small molecule | — | — |
| Subject | Diazepam | Small molecule | — | — |
| Subject | Lorazepam | Small molecule | — | — |