Ramelteon in the Prevention of Post-operative Delirium

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-24

Study Completion Date

2019-06-26

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)

Group Type EXPERIMENTAL

Riboflavin 100 mg

Intervention Type DRUG

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)

Ramelteon

Intervention Type DRUG

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

Microcrystalline Cellulose

Intervention Type DRUG

Placebo Comparator

Placebo

Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient)

Group Type PLACEBO_COMPARATOR

Riboflavin 100 mg

Intervention Type DRUG

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)

Microcrystalline Cellulose

Intervention Type DRUG

Placebo Comparator

Interventions

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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)

Intervention Type DRUG

Ramelteon

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

Intervention Type DRUG

Microcrystalline Cellulose

Placebo Comparator

Intervention Type DRUG

Other Intervention Names

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Rozerem Adherence marker

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No