Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age61+
SponsorUniversity of British Columbia

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

60 Participants
are divided into 2 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