Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Admitted to hospital following open cardiac surgery through midline sternotomy

🚫 You may not be able to join if…

• ● 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)
  • Current alcohol or substance use disorder as defined by the DSM-V
  • Patient already taking moderate or strong CYP3A inhibitors
  • Frequent use of medications for insomnia defined as >4 days per week.
  • Liver failure (Child-Pugh score B or C)
  • Renal failure (eGFR<30 ml/min/1.73 m2)
  • Pre-existing delirium (ICDSC score >3 or CAM/CAM-ICU positive) at time of consent
  • BMI>40 kg/m2
  • Known allergy or hypersensitivity to study drug
  • Inability to communicate in English

Where this trial is running

• St. Paul's Hospital, Vancouver, British Columbia, Canada

Who to contact

Ron Ree, MD · 604-561-8348 · ronmree@gmail.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06648681.