Delirium Clinical Trial
— RECOVEROfficial title:
A Randomized Double Blind Placebo Controlled Trial of Ramelteon in the Prevention of Post-operative Delirium in Older Patients Undergoing Orthopedic Surgery
Verified date | June 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 26, 2019 |
Est. primary completion date | June 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Up to Post Operative Day 2 | |
Primary | 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. | Post Operative Day 0: Post Anesthesia Care Unit Following Recovery from Anesthesia | |
Secondary | 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. | Postoperative Day 1 and Day 2 |
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