Suvorexant and Sleep/Delirium in ICU Patients (NCT04092894) | Clinical Trial Compass
CompletedPhase 4
Suvorexant and Sleep/Delirium in ICU Patients
United States100 participantsStarted 2020-02-28
Plain-language 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.
Who can participate
Age range60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Nighttime Wakefulness After Persistent Sleep Onset (WASO)
Timeframe: First night after extubation between 11:00pm and 6:00am