Phase 2 N=80 Randomized Quadruple-blind Prevention

Ramelteon in the Prevention of Post-operative Delirium

Delirium · Delirium, Dementia, Amnestic, Cognitive Disorders · Delayed Emergence From Anesthesia · Cognitive Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02324153 ↗

Enrolled (actual)

Serious AEs

3.8%

Results posted

Jun 2020

Primary outcome: Primary: Number of Participants With Delirium During Two Days Following Surgery — 3; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ramelteon (Drug); Microcrystalline Cellulose (Drug); Riboflavin 100 mg (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Delirium During Two Days Following Surgery	3; 2	—
PRIMARY Number of Participants With Delirium in the Post Anesthesia Care Unit (PACU)	7; 3	—
SECONDARY Delirium Rating Scale - Revised- 98 (DRS-R98) in Delirious Patients	19.7; 19.0	—

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.

Eligibility 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:
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02324153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.