jRCTs041240116招募中不适用
A randomized controlled phase II study of lemborexant for preventing delirium after gastrointestinal malignant tumor surgery
未提供0 个研究点目标入组 260 人开始时间: 2024年11月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 主要终点
- Occurrence of delirium
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 40age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with a clinical diagnosis of gastrointestinal malignancy
- •Patients over 40 years old
- •Patients with PS (ECOG) of 0 or 1
- •AST100 IU/L, ALT=<100IU/L
- •Total bilirubin=<2.0 mg/dl
- •Serum creatinine =<1.5 mg/dl
- •Patients who have given written consent to participate in the study.
排除标准
- •Persons diagnosed with dementia
- •Patients with mental illness (including alcoholism)
- •Patients with a history of regular use of sleeping pills (both BZ and non-BZ drugs)
- •Patients with a history of hypersensitivity to Lenvorexant, Ramelteon, Mianserin, or Trazodone
- •Patients taking drugs contraindicated with Lenvorexant, Ramelteon, Mianserin, or Trazodone.
- •Other subjects who are deemed inappropriate to participate in this study by the principal investigator and subinvestigators.
结局指标
主要结局
Occurrence of delirium
时间窗: first week after the start of postoperative study drug administration
whether or not it occurs in the first week after the start of postoperative study drug administration
次要结局
未报告次要终点
研究者
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