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Orexin Antagonist

Suvorexant for Postoperative Delirium (REPOSE Trial)

Phase 2

Recruiting

Led By Michael Devinney Jr, MD, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Scheduled postoperative inpatient overnight stay

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative day 0 through day 5 or discharge, whichever occurs first.

Summary

This trial will test if a drug can improve post-op sleep and reduce delirium in elderly patients after surgery.

Who is the study for?

This trial is for adults aged 65 and older who are English-speaking, scheduled for non-cardiac surgery with an overnight stay, and can consent to participate. Excluded are those with a BMI over 40, severe sleep apnea, certain psychotic disorders, liver failure, or using specific medications that affect suvorexant.

What is being tested?

The REPOSE Study is testing if suvorexant (20 mg), a drug given after surgery can improve sleep quality and reduce delirium severity compared to a placebo in older adults following non-cardiac surgery.

What are the potential side effects?

Suvorexant may cause drowsiness the next day, weakness, lightheadedness upon standing up too fast from sitting or lying down position (orthostatic hypotension), nightmares or abnormal dreams.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having surgery that does not involve my heart or brain.

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I am scheduled to stay in the hospital overnight after surgery.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having surgery that needs strict bowel rest afterwards, like stomach or pancreas surgery.

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I will have surgery that stops me from taking pills by mouth.

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I cannot complete the study's required questionnaires and assessments.

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I have used sedating sleep aids more than twice a week in the month before my surgery.

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I have had liver failure with an INR greater than 1.2 or experienced hepatic encephalopathy.

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I use a machine at home to help with my severe sleep apnea or breathing issues due to obesity.

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I haven't taken strong medication that affects liver enzymes in the last week.

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I am having surgery on my head that prevents wearing a headband.

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I am legally blind.

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I need home oxygen therapy for my lung condition.

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I haven't taken strong medication that affects liver enzymes in the last week.

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I am currently taking or plan to take digoxin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative day 0 through day 5 or discharge, whichever occurs first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative day 0 through day 5 or discharge, whichever occurs first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative day 0 through day 5 or discharge, whichever occurs first. for reporting.