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Ramelteon in the Prevention of Post-operative Delirium

NCT02324153 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-06-30

Study results available
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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.

Conditions

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

Interventions

DRUG

Ramelteon

1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered

DRUG

Microcrystalline Cellulose

Placebo Comparator

DRUG

Riboflavin 100 mg

Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)

Sponsors & Collaborators

Principal Investigators

  • Karin J Neufeld, MD MPH · Professor - Department of Psychiatry and Behavioral Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-24
Primary Completion
2019-06-26
Completion
2019-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02324153 on ClinicalTrials.gov