Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2027

Conditions
Delirium - PostoperativeCardiac SurgeryCardiac Surgery SubjectsOrexin AntagonistFeasibility StudiesSleepIn-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."

Trial Locations (1)

V6Z1Y6

St. Paul's Hospital, Vancouver

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

collaborator

Providence Health Care, British Columbia

UNKNOWN

collaborator

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

UNKNOWN

lead

University of British Columbia

OTHER