Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

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.

Conditions

• Delirium - Postoperative
• Cardiac Surgery
• Cardiac Surgery Subjects
• Orexin Antagonist
• Feasibility Studies
• Sleep
• In-hospital Mortality

Interventions

DRUG

Lemborexant 5 mg

The intervention is the oral administration of a study drug containing lemborexant 5 mg daily between 2000h and 0000h for the first 7 days following extubating/initiation criteria is met or until their hospital discharge or until the first diagnosis of delirium, whichever occurs first. Initiation criteria: I. The participant has been extubated for at least 2 hours II. all other sedative medications have been discontinued for \>1 hour III. the participant has a Richmond Agitation and Sedation Scale (RASS) score of \>-1 or a Pasero Opioid-induced Sedation Scale (POSS) score \<3. If satisfactory sleep is not achieved with the 5 mg dose of the study drug, as defined by a Richards Campbell Sleep Score \<50 within 1 hour, another insomnia medication may be administered on participant request and clinician judgement. If participants develop delirium, the study drug will be discontinued.

DRUG

Control (placebo) group

The control group will receive an oral placebo tablet daily between 2000h and 0000h for the first 7 days following when initiation criteria is met or until their hospital discharge, whichever occurs first. Initiation criteria: I. The participant has been extubated for at least 2 hours II. all other sedative medications have been discontinued for \>1 hour III. the participant has a Richmond Agitation and Sedation Scale (RASS) score of \>-1 or a Pasero Opioid-induced Sedation Scale (POSS) score \<3. If satisfactory sleep is not achieved with the 5 mg dose of the study drug, as defined by a Richards Campbell Sleep Score \<50 within 1 hour, another insomnia medication may be administered on participant request and clinician judgement. If participants develop delirium, the study drug will be discontinued.

Sponsors & Collaborators

• Eisai Inc.

  collaborator INDUSTRY

• Providence Health Care, British Columbia

  collaborator UNKNOWN

• St. Paul's Hospital, Vancouver (Providence Health Care)

  collaborator UNKNOWN

• University of British Columbia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

61 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2027-04-30

Completion

2027-04-30

Countries

• Canada

Study Locations