Grant: Project Grant
McMaster University
$459,000.00
Benzodiazepine-free cardiac anesthesia for reduction of postoperative delirium in the intensive care unit (B-Free): A multi-centre, randomized, cluster crossover trial
EF 2018-19
Résumé
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 study will include 16 centres around the world that will test the two policies in alternating sequence during 12 periods of 4 weeks. The feasibility of this trial design has been demonstrated in a pilot study that included 800 patients, and is being endorsed by the Canadian Perioperative Anesthesia Clinical Trials group (PACT). 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.
Programme
Project Grant
Bénéficiaire
Emplacement
Ontario, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database
Tel que publié
Id
391123
Name
Connolly Stuart J
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Randomized Controlled Trials 2
Projecttitle
Benzodiazepine-free cardiac anesthesia for reduction of postoperative delirium in the intensive care unit (B-Free): A multi-centre, randomized, cluster crossover trial
Programtype2
Operating Grants
Orgnameinp2
McMaster University
Cihramount2
$459,000
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Anesthesia; Cardiovascular Surgery; Delirium; Randomized Cluster Crossover Trial
Abstract
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 study will include 16 centres around the world that will test the two policies in alternating sequence during 12 periods of 4 weeks. The feasibility of this trial design has been demonstrated in a pilot study that included 800 patients, and is being endorsed by the Canadian Perioperative Anesthesia Clinical Trials group (PACT). 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.
Competitiondate
201809
Approvedterm2
2 yrs 0 mth
Pinamesdelim
Connolly, Stuart J; Jacobsohn, Eric
Approvedterm
2 ans 0 mois
Cihrcontribution2
~ $459,000~ $0~