NCT02324153

Ramelteon in the Prevention of Post-operative Delirium

A Randomized Double Blind Placebo Controlled Trial of Ramelteon in the Prevention of Post-operative Delirium in Older Patients Undergoing Orthopedic Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-03-24
• Primary completion: 2019-06-26
• Completion: 2019-06-26
• First posted: 2014-12-24
• Last updated: 2020-06-30
• Results posted: 2020-06-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study