Back to resultsRamelteon in the Prevention of Post-operative Delirium (RECOVER)
Primary Purpose
Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Delayed Emergence From Anesthesia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ramelteon
Microcrystalline Cellulose
Riboflavin 100 mg
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring Post-operative 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.
Sites / Locations
- Johns Hopkins Bayview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)
Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient)
Outcomes
Primary Outcome Measures
Number of Participants With Delirium During Two Days Following Surgery
Delirium DSM 5 based criteria informed by standardized history gathering, examination, cognitive evaluation using cognitive tests, informant interview, and medical record review) measured during Post-operative Day 1 and/or Day 2
Number of Participants With Delirium in the Post Anesthesia Care Unit (PACU)
Delirium (DSM 5 based criteria informed by standardized history gathering, examination, cognitive evaluation using cognitive tests, informant interview, and medical record review) measured once recovered from anesthesia.
Secondary Outcome Measures
Delirium Rating Scale - Revised- 98 (DRS-R98) in Delirious Patients
Measure Description: Delirium Rating Scale-Revised-98 (Severity items are rated on a scale of 0-3 and diagnostic items are rated on a scale of 0-2 or 0-3. The minimum score is 0. The maximum possible score for severity items is 39, while the maximum total score is 46. Higher scores indicate more severe delirium; score of 0 indicates no delirium.) Means and Standard Deviations were calculated from the maximum DRS-R98 score documented on Postoperative Day 1 and Day 2 for each participant who became delirious within each treatment arm.
Full Information
NCT ID
NCT02324153
First Posted
December 15, 2014
Last Updated
June 16, 2020
Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02324153
Brief Title
Ramelteon in the Prevention of Post-operative Delirium
Acronym
RECOVER
Official Title
A Randomized Double Blind Placebo Controlled Trial of Ramelteon in the Prevention of Post-operative Delirium in Older Patients Undergoing Orthopedic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 24, 2017 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Delayed Emergence From Anesthesia, Cognitive Disorders
Keywords
Post-operative Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient)
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Other Intervention Name(s)
Rozerem
Intervention Description
1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered
Intervention Type
Drug
Intervention Name(s)
Microcrystalline Cellulose
Intervention Description
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Riboflavin 100 mg
Other Intervention Name(s)
Adherence marker
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of Participants With Delirium During Two Days Following Surgery
Description
Delirium DSM 5 based criteria informed by standardized history gathering, examination, cognitive evaluation using cognitive tests, informant interview, and medical record review) measured during Post-operative Day 1 and/or Day 2
Time Frame
Up to Post Operative Day 2
Title
Number of Participants With Delirium in the Post Anesthesia Care Unit (PACU)
Description
Delirium (DSM 5 based criteria informed by standardized history gathering, examination, cognitive evaluation using cognitive tests, informant interview, and medical record review) measured once recovered from anesthesia.
Time Frame
Post Operative Day 0: Post Anesthesia Care Unit Following Recovery from Anesthesia
Secondary Outcome Measure Information:
Title
Delirium Rating Scale - Revised- 98 (DRS-R98) in Delirious Patients
Description
Measure Description: Delirium Rating Scale-Revised-98 (Severity items are rated on a scale of 0-3 and diagnostic items are rated on a scale of 0-2 or 0-3. The minimum score is 0. The maximum possible score for severity items is 39, while the maximum total score is 46. Higher scores indicate more severe delirium; score of 0 indicates no delirium.) Means and Standard Deviations were calculated from the maximum DRS-R98 score documented on Postoperative Day 1 and Day 2 for each participant who became delirious within each treatment arm.
Time Frame
Postoperative Day 1 and Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin J Neufeld, MD MPH
Organizational Affiliation
Professor - Department of Psychiatry and Behavioral Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32532654
Citation
Oh ES, Leoutsakos JM, Rosenberg PB, Pletnikova AM, Khanuja HS, Sterling RS, Oni JK, Sieber FE, Fedarko NS, Akhlaghi N, Neufeld KJ. Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial. Am J Geriatr Psychiatry. 2021 Jan;29(1):90-100. doi: 10.1016/j.jagp.2020.05.006. Epub 2020 May 16.
Results Reference
derived
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Ramelteon in the Prevention of Post-operative Delirium
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