REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant

Launched by DUKE UNIVERSITY · Feb 8, 2023

Keywords

ClinConnect Summary

The REPOSE Study is a research project aimed at finding out if a medication called suvorexant can help improve sleep and reduce confusion, known as delirium, in older adults after they have surgery. This study is specifically looking at adults aged 65 and older who are scheduled to have non-cardiac surgeries, meaning surgeries that do not involve the heart or brain. If you or a loved one meets these criteria and is able to give consent, you may be eligible to participate.

Participants in this study will receive suvorexant after their surgery to see if it helps them sleep better and feel less confused during recovery. It's important to note that certain individuals, such as those with specific medical conditions or who take certain medications, may not qualify for the study. Overall, this research aims to gather valuable information that could help improve the recovery experience for older patients undergoing surgery.

Gender

ALL

Eligibility 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, \*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
• Exclusionary Medications:
• • Moderate CYP3A inhibitors: Amprenavir, Aprepitant, Atazanavir, Ciprofloxacin, Diltiazem, Erythromycin, Fluconazole, Fosamprenavir, Imatinib, Verapamil, grapefruit juice.
• • Strong CYP3A inhibitors: Ketoconazole, Itraconazole, Posaconazole, Clarithromycin, Nefazodone, Ritonavir, Saquinavir, Nelfinavir, Indinavir, Boceprevir, Telaprevir, Telithromycin, Conivaptan
• • Moderate/Strong CYP3A inducers: Apalutamide, Carbamazepine, Enzalutamide, Ivosidenib, lumacaftor, Mitotane, Phenytoin, Rifampin, St. John's wort, Bosentan, Cenobamate, Dabrafenib, Efavirenz, Etravirine, Lorlatinib, Pexidartinib, Phenobarbital, Primidone, Sotorasib.
• • Sedating sleep aids: Mirtazapine, Trazodone, Flurazepam, Temazepam, Triazolam, Estazolam, Quazepam, Clonazepam, Lorazepam, Midazolam, Alprazolam, Diazepam, Zolpidem, Zaleplon, Eszopiclone, Diphenhydramine, Doxylamine, Hydroxyzine, Suvorexant, Doxepin