Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-Cho, Shizuoka, 411-8777, Japan.
Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
Surg Today. 2020 Dec;50(12):1681-1686. doi: 10.1007/s00595-020-02073-9. Epub 2020 Jul 8.
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.
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.
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.
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).
越来越多的老年胃癌患者被诊断出来，这凸显了预防术后谵妄的重要性。这项 II 期研究旨在评估围手术期使用雷美替胺治疗预防行胃切除术的老年患者术后谵妄的疗效。
本研究设计为单中心前瞻性 II 期研究。≥75 岁的患者符合条件。雷美替胺 8mg/天，从手术前 8 天开始给药，直至出院。使用重症监护病房意识模糊评估法进行术后谵妄评估。
2015 年 9 月至 2017 年 7 月，共纳入 83 例患者，其中 76 例符合条件并纳入分析。4 例患者（5%）发生术后谵妄（60%置信区间：3.0-8.7）。置信区间的上限低于预设的 13%阈值；因此，零假设被拒绝。
这项 II 期研究表明，围手术期给予雷美替胺治疗预防老年胃切除术患者术后谵妄是安全可行的。
本研究在 UMIN（UMIN 000018697）注册。
