Suvorexant and Sleep/Delirium in ICU Patients

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Sep 16, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how effective a medication called suvorexant is in helping older patients sleep better after heart surgery. The focus is on patients who are 60 years and older and are undergoing a specific type of surgery known as coronary artery bypass grafting (CABG). The trial will compare the effects of suvorexant, which is taken by mouth, to a placebo (a sugar pill with no active medication) over a week. Researchers will look closely at how well patients sleep, including how long it takes to fall asleep and how often they wake up during the night, using special monitoring equipment.

To be eligible for the study, participants must be 60 years or older and scheduled for elective heart surgery. Certain health conditions, like severe heart, kidney, or liver problems, as well as signs of confusion or other serious mental health issues, would exclude someone from participating. If eligible, participants can expect to take either the medication or placebo for seven nights after their surgery, while researchers observe their sleep patterns and any signs of confusion. This study aims to improve understanding of how to help patients recover from surgery by addressing sleep issues and preventing delirium, which is a type of confusion often seen in hospitalized patients.

Gender

ALL

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.