Status:
COMPLETED
Suvorexant and Sleep/Delirium in ICU Patients
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Insomnia
Sleep Fragmentation
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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...
Detailed Description
This is a prospective, randomized, placebo-controlled, blinded study. Participants will be enrolled preoperatively. After postoperative extubation, eligible patients will be randomly allocated in a 1:...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 60 years or older
- 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:
- Preoperative left ventricular ejection fraction of less than 30%
- Renal failure (creatinine \>2 mg/dl or dialysis dependence)
- Liver failure (CHILD-Pugh\>4)
- Coma (RASS\<-1)
- Signs and symptoms of delirium and agitation at time of enrollment (CAM-ICU positive)
- Montreal Cognitive Assessment (MoCA) below 23 at time of consent
- 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)
- Severe sleep apnea requiring home continuous positive airway pressure treatment
- Morbid obesity (BMI \>40)
- 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).
- Patients with known hypersensitivity to study medications
- English language limitations (Sleep assessment and delirium assessment tools are only validated in English)
- Patients enrolled in other interventional studies which could confound the primary endpoint.
Exclusion
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04092894
Start Date
February 28 2020
End Date
July 1 2025
Last Update
October 27 2025
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Montefiore Medical Center/Albert Einstein college of Medicine
The Bronx, New York, United States, 10467