Clinical trial NCT02324153: Ramelteon in the Prevention of Post-operative Delirium
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delirium
Delirium, Dementia, Amnestic, Cognitive Disorders
Delayed Emergence From Anesthesia
Cognitive Disorders
Keywords: Post-operative Delirium
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-12-24
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

  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.

Primary outcomes:
measure: Number of Participants With Delirium During Two Days Following Surgery
timeFrame: Up to Post Operative Day 2
measure: Number of Participants With Delirium in the Post Anesthesia Care Unit (PACU)
timeFrame: Post Operative Day 0: Post Anesthesia Care Unit Following Recovery from Anesthesia
Secondary outcomes:
measure: Delirium Rating Scale - Revised- 98 (DRS-R98) in Delirious Patients
timeFrame: Postoperative Day 1 and Day 2
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Professor - Department of Psychiatry and Behavioral Sciences
name: Karin J Neufeld, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.