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Completed

NCT Number: NCT02324153

Ramelteon in the Prevention of Post-operative Delirium

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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Key information

Conditions

Delirium Cognition Disorders Cognitive Disorders Cognitive Dysfunction Confusion Delayed Emergence From Anesthesia Delirium, Dementia, Amnestic, Cognitive Disorders Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Ramelteon

Drug

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

Other names: Rozerem

Microcrystalline Cellulose

Drug

Placebo Comparator

Riboflavin 100 mg

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)

Other names: Adherence marker

Primary outcomes

  1. Number of Participants With Delirium During Two Days Following Surgery

    Time frame: Up to Post Operative Day 2

    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

  2. Number of Participants With Delirium in the Post Anesthesia Care Unit (PACU)

    Time frame: Post Operative Day 0: Post Anesthesia Care Unit Following Recovery from Anesthesia

    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 outcomes

  1. Delirium Rating Scale - Revised- 98 (DRS-R98) in Delirious Patients

    Time frame: Postoperative Day 1 and Day 2

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: RECOVER

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 24, 2014
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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