Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT04092894
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04092894
Study Brief:
Protocol Section:
NCT04092894