Ramelteon in the Prevention of Post-operative Delirium

Completed · Phase 2 · Has a placebo group

Conditions studied: Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Delayed Emergence From Anesthesia, Cognitive Disorders

In brief

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.

Key facts

Study ID

NCT02324153

Run by

Johns Hopkins University

People needed

80

Starts

2017-03-24

Expected to finish

2019-06-26

Last updated by the study team

2020-06-30

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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:
• ramelteon
• melatonin
• fluvoxamine
• rifampin
• ketoconazole
• 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.

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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