ClinicalTrialsFinder
RecruitingPhase 4NCT05069428

Delirium Reduction With Ramelteon

Sponsor

Centennial Medical Center

Enrollment

506 participants

Start Date

Mar 26, 2023

Study Type

INTERVENTIONAL

Conditions

Delirium

Summary

The overall purpose of this study is to identify a medication that might treat and/or prevent delirium in intensive care unit (ICU). Currently, there is no proven medical therapy for prevention or treatment of delirium. Ramelteon is a medication approved for insomnia. We hypothesize that ramelteon may help regulate the day/night cycle and decrease ICU delirium.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Medical or surgical ICU patient
  • Ability to take oral or nasogastric tube within 48 hours of admission to ICU
  • Expected ICU length of stay and life expectancy at least 48 hours
  • Patient or POA capable of signing informed consent within 48 hours of ICU admission

Exclusion Criteria11

  • Past medical history includes cirrhosis
  • Active alcohol withdrawal
  • Patients taking fluvoxamine prior to admission
  • Self-reported hypersensitivity to ramelteon
  • Incarcerated patients
  • Pregnant patients
  • Patients with acute neurological conditions including brain abscess, head bleed, meningitis
  • Patients who are transferred from an outside hospital where they have resided for greater than 4 days
  • Non-English speaking patients
  • Hearing-impaired patients requiring sign language for communication
  • Visually-impaired patients

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRamelteon 8mg

administered crushed, orally at 20:30

Locations(1)

Centennial Medical Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05069428

Related Trials

Neurosteer Bedside Monitoring System

NCT067187641 location

Nocturnal Hypoxia in Geriatric Patients After Hip Fracture

NCT040074322 locations

Computer-assisted Cognitive Stimulation Treatment for Delirium

NCT075632441 location

Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery

NCT069692871 location

TaVNS for Delirium

NCT072580821 location