Ramelteon in the Prevention of Post-operative Delirium

Phase 2 Completed 80 enrolled Johns Hopkins University National Institute on Aging (NIA) · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2017-03-24
Primary completion: 2019-06-26
Completion: 2019-06-26

Outcome

Missed primary endpoint

paper CONCLUSION: In older patients undergoing elective primary or revision hip or knee replacement, ramelteon was not efficacious in preventing postoperative delirium. PMID 32532654 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramelteon	Unknown	8 mg	Oral
Background	Riboflavin	Other / unclassified	100 mg	—