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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative day 0 through day 5 or discharge, whichever occurs first.
Awards & highlights
REPOSE Trial 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.Check my eligibility
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.See study design
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.
REPOSE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery that does not involve my heart or brain.
Select...
I am scheduled to stay in the hospital overnight after surgery.
Select...
I am 65 years old or older.
REPOSE Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total Sleep Time
Secondary outcome measures
Postoperative Delirium Severity score
REPOSE Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Suvorexant ArmActive Control1 Intervention
Group II: Placebo ArmPlacebo Group1 Intervention
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,386 Total Patients Enrolled
6 Trials studying Delirium
546 Patients Enrolled for Delirium
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,016 Total Patients Enrolled
2 Trials studying Delirium
323 Patients Enrolled for Delirium
Michael Devinney Jr, MD, PhDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery that needs strict bowel rest afterwards, like stomach or pancreas surgery.You have a very high body mass index.I will have surgery that stops me from taking pills by mouth.I cannot complete the study's required questionnaires and assessments.I have used sedating sleep aids more than twice a week in the month before my surgery.I am having surgery that does not involve my heart or brain.I have had liver failure with an INR greater than 1.2 or experienced hepatic encephalopathy.I use a machine at home to help with my severe sleep apnea or breathing issues due to obesity.You have been diagnosed with narcolepsy in the past.I haven't taken strong medication that affects liver enzymes in the last week.I am having surgery on my head that prevents wearing a headband.I am scheduled to stay in the hospital overnight after surgery.I am 65 years old or older.I am legally blind.I need home oxygen therapy for my lung condition.I haven't taken strong medication that affects liver enzymes in the last week.I am currently taking or plan to take digoxin.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: Suvorexant Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there space available to join this clinical research endeavor?
"The clinicaltrials.gov entry for this trial suggests that recruitment is no longer active, as the study was posted on March 1st 2023 and last edited February 20th of the same year. However, 145 other trials are currently looking to recruit new patients at this time."
Answered by AI
What risks does the Suvorexant Arm pose to human health?
"Suvorexant Arm's safety was assigned a score of 2 based on data from this Phase 2 trial. While there is evidence for its security, the efficacy has yet to be confirmed in clinical trials."
Answered by AI
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