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Not Yet Recruiting
NCT05733286
REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant
Conditions: Delirium in Old Age
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: 1
Phase: PHASE2
Enrollment: 130
Sponsor: Duke University
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.
Eligibility Criteria
Inclusion Criteria:Age 65 and olderUndergoing non-cardiac, non-intracranial surgery, any surgical procedure not involving the skull, brain, cerebrovascular structuresScheduled postoperative inpatient overnight stayAble to give informed consent or has legally authorized representative able to give informed consent on their behalfEnglish-speakingExclusion Criteria:Inmate of correctional facilityBody mass index> 40Legal blindnessUnable to perform study related questionnaires and assessmentsUse 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.History of psychotic disorder, including schizophrenia, schizoaffective disorder, schizophreniform or brief psychotic disorder.History of liver failure with documented international normalized ratio (INR) of >1.2 or with history of hepatic encephalopathyHistory of severe sleep apnea or obesity hypoventilation syndrome requiring home bilevel positive airway pressure therapy or home ventilator or other forms of noninvasive ventilationChronic lung disease requiring home oxygen therapyHistory of narcolepsyUse of systemic (oral, intravenous, intramuscular, subcutaneous) moderate or strong CYP3A inhibitors within 1 week prior to surgery, listed in section 5.5.Current or planned administration of digoxin, or is currently experiencing digoxin toxicityUndergoing surgery that will result in inability to take medications by mouth including laryngectomy, tracheostomy, and oral resection/reconstructive surgeryUndergoing surgery that will require postoperative strict bowel rest, including gastrectomy, esophagectomy, and pancreaticoduodenectomyUndergoing surgery in an area that will make it unsafe to wear a headband, such as scalp or forehead procedures.Inappropriate for study inclusion based on the judgement of the principal investigator
Source: ClinicalTrials.gov (NCT05733286). StuddyBuddy aggregates publicly available trial information.