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Surgery Today
Published in: Surgery Today 12/2020

01-12-2020 | Gastrectomy | Original Article

A phase II study of ramelteon for the prevention of postoperative delirium in elderly patients undergoing gastrectomy

Authors: Shinsaku Honda, Kenichiro Furukawa, Rie Makuuchi, Tomoyuki Irino, Masanori Tokunaga, Yutaka Tanizawa, Etsuro Bando, Taiichi Kawamura, Kaori Shinsato, Teruaki Matsumoto, Masanori Terashima

Published in: Surgery Today | Issue 12/2020

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Abstract

Purpose

The growing number of cases of gastric cancer being diagnosed in elderly patients highlights the importance of preventing postoperative delirium. This phase II study aimed to evaluate the efficacy of perioperative treatment with ramelteon for preventing postoperative delirium in elderly patients undergoing gastrectomy.

Methods

This study was designed as a single-institute prospective phase II study. Patients ≥ 75 years old were eligible. Ramelteon 8 mg/day was administered from 8 days before the operation until discharge. Postoperative delirium was evaluated using the Confusion Assessment Method-Intensive Care Unit flow sheet.

Results

Between September 2015 and July 2017, a total of 83 patients were enrolled, 76 of whom were eligible and included in the analysis. Postoperative delirium was observed in four patients (5%) (60% confidence interval: 3.0–8.7). The upper margin of the confidence interval was lower than the prespecified threshold of 13%; therefore, the null hypothesis was rejected.

Conclusion

This phase II study suggested that the perioperative administration of ramelteon is safe and feasible for preventing postoperative delirium in elderly patients undergoing gastrectomy.
Trial registration This study was registered at UMIN (UMIN 000018697)
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Metadata
Title
A phase II study of ramelteon for the prevention of postoperative delirium in elderly patients undergoing gastrectomy
Authors
Shinsaku Honda
Kenichiro Furukawa
Rie Makuuchi
Tomoyuki Irino
Masanori Tokunaga
Yutaka Tanizawa
Etsuro Bando
Taiichi Kawamura
Kaori Shinsato
Teruaki Matsumoto
Masanori Terashima
Publication date
01-12-2020
Publisher
Springer Singapore
Published in
Surgery Today / Issue 12/2020
Print ISSN: 0941-1291
Electronic ISSN: 1436-2813
DOI
https://doi.org/10.1007/s00595-020-02073-9

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