drugset / Trial / NCT06648681
Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients
Phase 2
Not yet recruiting
60 enrolled
University of British Columbia
Eisai Inc. · collabProvidence Health Care, British Columbia · collabSt. Paul's Hospital, Vancouver (Providence Health Care) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
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.
Timeline
- Start
- 2025-05-01
- Primary completion
- 2027-04-30
- Completion
- 2027-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lemborexant | Small molecule | 5 mg | Oral |