Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Lembrorexant is an orexin antagonist, originally approved for sleep, that may also reduce the incidence of delirium. The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium, and improving sleep.

NCT Number	NCT06648681
Lead Sponsor	University of British Columbia Collaborators: Eisai Inc., Providence Health Care, British Columbia, St. Paul's Hospital, Vancouver (Providence Health Care)
Conditions	Delirium - Postoperative, Cardiac Surgery, Cardiac Surgery Subjects, Orexin Antagonist, Feasibility Studies, Sleep, In-hospital Mortality
Enrollment	60 participants
Start Date	2025-05-01
Primary Completion	2027-04-30 (estimated)
Study Completion	2027-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-04-23