A Phase 2 interventional study of Ramelteon and Microcrystalline Cellulose in Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders and Delayed Emergence From Anesthesia, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-06-30.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Prevention
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.
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.
1,058 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 80 is below the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Current medications that include:
Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)
Drug: Ramelteon · Drug: Microcrystalline Cellulose · Drug: Riboflavin 100 mg
Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient)
Drug: Microcrystalline Cellulose · Drug: Riboflavin 100 mg
1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered
Also known as: Rozerem
Placebo Comparator
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)
Also known as: Adherence marker
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
Time frame: Up to Post Operative 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.
Time frame: Post Operative Day 0: Post Anesthesia Care Unit Following Recovery from Anesthesia
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.
Time frame: Postoperative Day 1 and Day 2
| Milestone | Treatment | Placebo |
|---|---|---|
| Started | 41 | 39 |
| Completed | 33 | 38 |
| Not completed | 8 | 1 |
| Withdrew: Withdrawal by subject | 4 | 1 |
| Withdrew: Surgery postponed after randomization | 3 | 0 |
| Withdrew: Developed delirium preoperatively | 1 | 0 |
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
| Participants | Treatment | Placebo |
|---|---|---|
| Number of Participants With Delirium During Two Days Following Surgery | 3 | 2 |
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.
| Participants | Treatment | Placebo |
|---|---|---|
| Number of Participants With Delirium in the Post Anesthesia Care Unit (PACU) | 7 | 3 |
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.
| score on a scale | Treatment | Placebo |
|---|---|---|
| Delirium Rating Scale - Revised- 98 (DRS-R98) in Delirious Patients | 19.7 ± 8.0 | 19.0 ± 11.3 |
Collected over 30-day follow-up after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/41 (0%) | 3/41 (7.3%) | 13/41 (31.7%) |
| Placebo | 0/39 (0%) | 0/39 (0%) | 13/39 (33.3%) |
| Event | Treatment | Placebo |
|---|---|---|
| BigeminyCardiac disorders | 1/41 | 0/39 |
| FallInjury, poisoning and procedural complications | 1/41 | 0/39 |
| HypotensionCardiac disorders | 1/41 | 0/39 |
| Event | Treatment | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 5/41 | 2/39 |
| DizzinessEar and labyrinth disorders | 1/41 | 2/39 |
| Eye disorders and eye painEye disorders | 2/41 | 0/39 |
| FlushingSkin and subcutaneous tissue disorders | 0/41 | 1/39 |
| PruritusSkin and subcutaneous tissue disorders | 0/41 | 1/39 |
| HypotensionCardiac disorders | 1/41 | 1/39 |
| Reactive leukocytosisBlood and lymphatic system disorders | 0/41 | 1/39 |
| SyncopeCardiac disorders | 1/41 | 1/39 |
| HematuriaRenal and urinary disorders | 0/41 | 1/39 |
| Urinary retentionRenal and urinary disorders | 1/41 | 1/39 |
Patients randomized to either treatment with ramelteon or placebo
| Age, Continuous(years) | Treatment | Placebo | Total |
|---|---|---|---|
| Mean | 74.3 ± 5.5 | 75.4 ± 5.0 | 74.9 ± 5.2 |
| Sex: Female, Male(Participants) | Treatment | Placebo | Total |
|---|---|---|---|
| Female | 19 | 24 | 43 |
| Male | 14 | 14 | 28 |
| Race (NIH/OMB)(Participants) | Treatment | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 6 | 12 |
| White | 27 | 32 | 59 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment | Placebo | Total |
|---|---|---|---|
| United States | 33 | 38 | 71 |
| DRS-R98 Total(units on a scale) | Treatment | Placebo | Total |
|---|---|---|---|
| Mean | 2.2 ± 2.6 | 2.6 ± 3.0 | 2.4 ± 2.8 |
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