About this trial
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.
Eligibility criteria
Qualifiers
Admitted to hospital following open cardiac surgery through midline sternotomy
Disqualifiers
● Known severe obstructive sleep apnea diagnosed by polysomnography or STOPBANG score > 5
Periodic limb movement disorder or restless legs syndrome
Narcolepsy
Somnolence (Pasero Opioid Sedation Scale (POSS) >2)
Trial design
Treatments tested in this trial
- Lemborexant 5 mg
- Control (placebo) group
Treatment groups
Sponsors and collaborators
University of British Columbia
Lead sponsor
Eisai Inc.
Collaborator
Providence Health Care, British Columbia
Collaborator
St. Paul's Hospital, Vancouver (Providence Health Care)
Collaborator