Overview

Suvorexant and Sleep/Delirium in ICU Patients

Status:
Recruiting

Trial end date:
2022-07-01

Target enrollment:
0

Participant gender:
All

Summary

Investigators will evaluate the efficacy of postoperative oral suvorexant treatment on nighttime wakefulness after persistent sleep onset (WASO) among adult cardiac surgical patients recovering in the cardiac intensive care unit (ICU). The study include patients ≥ 60 years old undergoing coronary artery bypass graft surgery (CABG), with or without valve surgery (aortic or mitral). Patients will receive either oral suvorexant or placebo for 7 nights starting the night after extubation. The primary hypothesis is that suvorexant compared with placebo decreases WASO, as measured by a specialized electroencephalogram (EEG), the SedLine monitor, during the first night in the cardiac ICU. Investigators will also assess total sleep time (TST), time to sleep onset (TSO), and postoperative delirium and delirium-free days.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Beth Israel Deaconess Medical Center

Collaborator:

Merck Sharp & Dohme Corp.

Treatments:

Suvorexant

Criteria

Inclusion criteria:

1. Age 60 years or older

2. Undergoing elective coronary artery bypass graft surgery with or without aortic and/or
mitral valve replacement, who are expected to be transferred to the ICU
postoperatively

Exclusion criteria:

1. Preoperative left ventricular ejection fraction of less than 30%

2. Renal failure (creatinine >2 mg/dl or dialysis dependence)

3. Liver failure (CHILD-Pugh>4)

4. Coma (RASS<-1)

5. Signs and symptoms of delirium and agitation at time of enrollment (CAM-ICU positive)

6. Montreal Cognitive Assessment (MoCA) below 23 at time of consent

7. Psychiatric or neurologic diseases (including chronic benzodiazepine use, bipolar
disorder, psychotic disorder, posttraumatic stress disorder, requirement of
prophylactic psychiatric medication, evidence of acute depression on screening visit,
preexisting cognitive impairment, Alzheimer disease, Parkinson's disease, medications
for cognitive decline, history of recent seizures (within 1 year prior visit),
alcoholism or documented history of alcohol abuse, and narcolepsy)

8. Severe sleep apnea requiring home continuous positive airway pressure treatment

9. Morbid obesity (BMI >40)

10. Known or suspected pregnancy (there are no adequate and well-controlled studies of
suvorexant in pregnant women. Based on animal data, Suvorexant may cause fetal harm).

11. Patients with known hypersensitivity to study medications

12. English language limitations (Sleep assessment and delirium assessment tools are only
validated in English)

13. Patients enrolled in other interventional studies which could confound the primary
endpoint.