Abstract | OBJECTIVE: DESIGN: A stratified, double-blind, randomized, placebo-controlled trial (UMIN000028436, jRCTs031180054). SETTING: Tertiary medical center. PARTICIPANTS: Patients aged older than or equal to 65 years undergoing elective surgery under general anesthesia. INTERVENTION:
Ramelteon (8 mg orally) or placebo ( lactose) for six nights (the preoperative night and five consecutive nights from postoperative day 1 to 5) at around 9 P.M. MEASUREMENTS: Patients were screened for postoperative delirium using the Confusion Assessment Method for the Intensive Care Unit twice daily until the sixth postoperative day. Patients with positive results were referred to a consultant psychiatrist to establish the diagnosis of delirium. RESULTS: A total of 108 patients were randomly assigned to receive ramelteon (n = 55) or placebo (n = 53). Most of the patients' characteristics were reasonably well-balanced between the two groups. The stratified log-rank test showed no significant difference in preventing postoperative delirium between ramelteon and placebo (χ2 = 0.30, degrees of freedom = 1, p = 0.60). The Cox proportional hazard ratio for ramelteon compared to placebo was 1.40 (95% confidence interval: 0.40-4.85, χ2 for likelihood ratio test = 0.29, degrees of freedom = 1, p = 0.60). CONCLUSION:
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Authors | Mariko Kinouchi, Takahiro Mihara, Masataka Taguri, Makoto Ogura |
Journal | The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry
(Am J Geriatr Psychiatry)
Vol. 31
Issue 12
Pg. 1178-1189
(12 2023)
ISSN: 1545-7214 [Electronic] England |
PMID | 37567839
(Publication Type: Randomized Controlled Trial, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2023 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved. |
Chemical References |
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Topics |
- Aged
- Humans
- Emergence Delirium
(chemically induced, complications, drug therapy)
- Delirium
(epidemiology)
- Indenes
(adverse effects)
- Anesthesia, General
(adverse effects)
- Double-Blind Method
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