REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant

Description

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.

Conditions

Delirium in Old Age

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Efficacy of Suvorexant to Improve Postoperative Sleep and Reduce Delirium Severity in Older Surgical Patients: A Double-blinded, Randomized, Placebo-controlled Trial

REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant

Condition
Delirium in Old Age
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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, \*See list Below.
  • 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, \*See list below
  • 12. Use of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strong CYP3A inducers within 1 week prior to surgery, \*See list below.
  • 13. Current or planned administration of digoxin, or is currently experiencing digoxin toxicity
  • 14. Undergoing surgery that will result in inability to take medications by mouth including laryngectomy, tracheostomy, and oral resection/reconstructive surgery
  • 15. Undergoing surgery that will require postoperative strict bowel rest, including gastrectomy, esophagectomy, and pancreaticoduodenectomy
  • 16. Undergoing surgery in an area that will make it unsafe to wear a headband, such as scalp or forehead procedures.
  • 17. Inappropriate for study inclusion based on the judgement of the principal investigator

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Duke University,

Michael Devinney Jr, MD, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2025-10