{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Oh ES"],"funding":["NIA NIH HHS","National Institute on Aging"],"pagination":["90-100"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8809889"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["29(1)"],"pubmed_abstract":["<h4>Objectives</h4>Postoperative delirium, associated with negative consequences including longer hospital stays and worse cognitive and physical outcomes, is frequently accompanied by sleep-wake disturbance. Our objective was to evaluate the efficacy and short-term safety of ramelteon, a melatonin receptor agonist, for the prevention of postoperative delirium in older patients undergoing orthopedic surgery.<h4>Design</h4>A quadruple-masked randomized placebo-controlled trial (Clinical Trials.gov NCT02324153) conducted from March 2017 to June 2019.<h4>Setting</h4>Tertiary academic medical center.<h4>Participants</h4>Patients aged 65 years or older, undergoing elective primary or revision hip or knee replacement.<h4>Intervention</h4>Ramelteon (8 mg) or placebo MEASUREMENTS: Eighty participants were randomized to an oral gel cap of ramelteon or placebo for 3 consecutive nights starting the night before surgery. Trained research staff conducted delirium assessments for 3 consecutive days starting on postoperative day (POD) 0, after recovery from anesthesia, and on to POD2. A delirium diagnosis was based upon DSM-5 criteria determined by expert panel consensus.<h4>Results</h4>Of 80 participants, five withdrew consent (one placebo, four ramelteon) and four were excluded (four ramelteon) after randomization. Delirium incidence during the 2 days following surgery was 7% (5 of 71) with no difference between the ramelteon versus placebo: 9% (3 of 33) and 5% (2 of 38), respectively. The adjusted odds ratio for postoperative delirium as a function of assignment to the ramelteon treatment arm was 1.28 (95% confidence interval: 0.21-7.93; z-value 0.27; p-value = 0.79). Adverse events were similar between the two groups.<h4>Conclusion</h4>In older patients undergoing elective primary or revision hip or knee replacement, ramelteon was not efficacious in preventing postoperative delirium."],"journal":["The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry"],"pubmed_title":["Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial."],"pmcid":["PMC8809889"],"funding_grant_id":["R21 AG050850","R01 AG057725","R01AG057725","R21AG050850"],"pubmed_authors":["Sieber FE","Khanuja HS","Sterling RS","Leoutsakos JM","Neufeld KJ","Rosenberg PB","Oni JK","Oh ES","Fedarko NS","Akhlaghi N","Pletnikova AM"],"additional_accession":[]},"is_claimable":false,"name":"Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial.","description":"<h4>Objectives</h4>Postoperative delirium, associated with negative consequences including longer hospital stays and worse cognitive and physical outcomes, is frequently accompanied by sleep-wake disturbance. Our objective was to evaluate the efficacy and short-term safety of ramelteon, a melatonin receptor agonist, for the prevention of postoperative delirium in older patients undergoing orthopedic surgery.<h4>Design</h4>A quadruple-masked randomized placebo-controlled trial (Clinical Trials.gov NCT02324153) conducted from March 2017 to June 2019.<h4>Setting</h4>Tertiary academic medical center.<h4>Participants</h4>Patients aged 65 years or older, undergoing elective primary or revision hip or knee replacement.<h4>Intervention</h4>Ramelteon (8 mg) or placebo MEASUREMENTS: Eighty participants were randomized to an oral gel cap of ramelteon or placebo for 3 consecutive nights starting the night before surgery. Trained research staff conducted delirium assessments for 3 consecutive days starting on postoperative day (POD) 0, after recovery from anesthesia, and on to POD2. A delirium diagnosis was based upon DSM-5 criteria determined by expert panel consensus.<h4>Results</h4>Of 80 participants, five withdrew consent (one placebo, four ramelteon) and four were excluded (four ramelteon) after randomization. Delirium incidence during the 2 days following surgery was 7% (5 of 71) with no difference between the ramelteon versus placebo: 9% (3 of 33) and 5% (2 of 38), respectively. The adjusted odds ratio for postoperative delirium as a function of assignment to the ramelteon treatment arm was 1.28 (95% confidence interval: 0.21-7.93; z-value 0.27; p-value = 0.79). Adverse events were similar between the two groups.<h4>Conclusion</h4>In older patients undergoing elective primary or revision hip or knee replacement, ramelteon was not efficacious in preventing postoperative delirium.","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Jan","modification":"2026-05-28T07:09:34.292Z","creation":"2025-02-19T03:53:27.263Z"},"accession":"S-EPMC8809889","cross_references":{"pubmed":["32532654"],"doi":["10.1016/j.jagp.2020.05.006"]}}