REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study will evaluate the effectiveness of postoperative administration of a drug called suvorexant, to improve postoperative sleep and decrease the severity of delirium (serious confusion) in adults 65 years and older undergoing non-cardiac surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University
• Collaborator: Merck Sharp & Dohme LLC
• Treatments: Suvorexant

Criteria

Inclusion Criteria:

1. Age 65 and older

2. Undergoing non-cardiac, non-intracranial surgery, any surgical procedure not involving the skull, brain, cerebrovascular structures

3. Scheduled postoperative inpatient overnight stay

4. Able to give informed consent or has legally authorized representative able to give informed consent on their behalf

5. English-speaking

Exclusion Criteria:

1. Inmate of correctional facility

2. Body mass index> 40

3. Legal blindness

4. Unable to perform study related questionnaires and assessments

5. Use of outpatient sedating sleep aids > 2 times per any week in 1 month preceding day of surgery. Sedating sleep aids, listed in section 5.5.

6. History of psychotic disorder, including schizophrenia, schizoaffective disorder, schizophreniform or brief psychotic disorder.

7. History of liver failure with documented international normalized ratio (INR) of >1.2 or with history of hepatic encephalopathy

8. History of severe sleep apnea or obesity hypoventilation syndrome requiring home bilevel positive airway pressure therapy or home ventilator or other forms of noninvasive ventilation

9. Chronic lung disease requiring home oxygen therapy

10. History of narcolepsy

11. Use of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strong CYP3A inhibitors within 1 week prior to surgery, listed in section 5.5.

12. Current or planned administration of digoxin, or is currently experiencing digoxin toxicity

13. Undergoing surgery that will result in inability to take medications by mouth including laryngectomy, tracheostomy, and oral resection/reconstructive surgery

14. Undergoing surgery that will require postoperative strict bowel rest, including gastrectomy, esophagectomy, and pancreaticoduodenectomy

15. Undergoing surgery in an area that will make it unsafe to wear a headband, such as scalp or forehead procedures.

16. Inappropriate for study inclusion based on the judgement of the principal investigator