Efficacy of Suvorexant on Post-operative Sleep Disturbance

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05823844
Phase
PHASE4
Status
Recruiting
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Conditions

  • Postoperative Delirium
  • Postoperative Insomnia

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Suvorexant — DRUG
    Suvorexant (Belsomra™) is an orexin receptor antagonist that will be administered as 2 tablets (10mg each) for a starting dose of 20mg. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant.
  • Placebo — DRUG
    The placebo pill will look identical to Suvorexant and will be taken as 2 tablets.

Study Details

The study is a parallel group, double blind, randomized trial. Subjects will be recruited from individuals undergoing elective surgery for orthopedic, abdominal, urologic, gynecologic or spine reasons. Out of 92 subjects, one experimental group of 46 subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). The other control group of 46 subjects will receive placebo (two tablets) and treatment as usual.

Key Dates

Start date
May 1, 2023
Status verified
May 2024
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Suvorexant administration
    Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
  • Placebo Comparator: Placebo administration
    Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).

Primary Outcome Measure

Total sleep time on day 0 (TST) [ Time Frame: Day 0 of in-hospital stay after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital BuildingNew YorkNew York10032/10034
Paul S. Garcia, MD PhD
[email protected]
212-304-7523
Terry E. Goldberg, PhD (SUB_INVESTIGATOR)
Paul S. Garcia, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building· New York, NY

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