Not Yet RecruitingPhase 2

Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

Canada60 participantsStarted 2025-05-01

Plain-language 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.

Who can participate

Age range61 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Admitted to hospital following open cardiac surgery through midline sternotomy Exclusion Criteria: * ● 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

What they're measuring

Recruitment Feasibility

Timeframe: Prior to Surgery, for the duration of the study recruitment period, estimated to be approximately 2 years

Data Collection Adherence

Timeframe: Post-operative day 0 to 7

Trial details

NCT IDNCT06648681

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Ron Ree, MD

604-561-8348 ronmree@gmail.com