Ramelteon in the Prevention of Post-operative Delirium

• Status: Completed
• Trial end date: 2019-06-26
• Target enrollment: 0
• Participant gender: All

Summary

This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness and safety of peri-operative administration of ramelteon, a melatonin agonist in the prevention of postoperative delirium.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University; Karin J. Neufeld MD MPH
• Collaborator: National Institute on Aging (NIA)
• Treatments: Riboflavin

Criteria

• Planned orthopedic surgery under general or regional anesthesia and post-operative inpatient stay

• 65 years of age or older

• Mini-mental Status Exam (MMSE) score of 15 or greater prior to surgery;

• Ability to understand, speak, read and write English.

Exclusion Criteria:

• Delirium diagnosis on the Confusion Assessment Method instrument at baseline

• Is unable to give informed consent due to cognitive impairment and a suitable legally authorized representative (LAR) cannot be identified

• Declines participation

• Current medications that include:

1. ramelteon

2. melatonin

3. fluvoxamine

4. rifampin

5. ketoconazole

6. fluconazole

• History of ramelteon or riboflavin intolerance

• Heavy daily alcohol intake by medical record or history

• Current moderate to severe liver failure (as defined by Charlson criteria

• Evidence of Systemic Inflammatory Response Syndrome (SIRS) as measured by > 2 criteria8)

• Presence of a condition that in the opinion of the PI compromises patient safety or data quality if enrolled in the study.