Expired Study
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Baltimore, Maryland 21224


Purpose:

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.


Study summary:

This trial will randomize older aged patients undergoing general or regional anesthesia for orthopedic surgical procedures to three perioperative doses of a melatonin agonist, ramelteon, and placebo in a masked double blind fashion. The primary outcomes are 1) the incidence of post-operative delirium in the recovery period in the Postoperative Anesthesia Care Unit and on post-operative days 1 and 2 following surgery, and 2) the safety of ramelteon as documented by the presence of adverse events in the follow-up period.


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.


NCT ID:

NCT02324153


Primary Contact:

Principal Investigator
Karin J Neufeld, MD MPH
Associate Professor - Department of Psychiatry and Behavioral Sciences


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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