Phase 2
Completed N=80
Ramelteon in the Prevention of Post-operative Delirium
Delirium · Delirium, Dementia, Amnestic, Cognitive Disorders · Delayed Emergence From Anesthesia · Cognitive Disorders
Source: ClinicalTrials.gov NCT02324153 ↗
Enrolled (actual)
80
Serious AEs
3.8%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants With Delirium During Two Days Following Surgery — 3; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Delirium During Two Days Following Surgery |
3; 2 | — |
| PRIMARY Number of Participants With Delirium in the Post Anesthesia Care Unit (PACU) |
7; 3 | — |
| SECONDARY Delirium Rating Scale - Revised- 98 (DRS-R98) in Delirious Patients |
19.7; 19.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02324153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.