JPRN-jRCTs041200062招募中2 期
A multicenter phase II randomized trial of ramelteon on prevention of postoperative delirium after gastrectomy in elderly patient
Terashima Masanori0 个研究点目标入组 210 人开始时间: 2020年11月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 75age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically proven adenocarcinoma of the stomach
- •2) Planned radical gastrectomy other than local resection
- •3) Age>=75 years old
- •4) PS 0 or 1
- •5) Oral medication able to be ingested without bowel obstruction or bleeding
- •6) WBC >= 3,000 /mm3
- •PLT >= 100,000 /mm3
- •AST<=100 IU/L,ALT<=100 IU/L
- •T-Bil<=2.0 mg/dl
- •Cre<= 1.5 mg/dl
- •7)Written informed consent
排除标准
- •1) Dementia
- •2) Psychologic disorders (including habitual use of sleeping medicine, and alcoholism)
- •3) CAM-ICU not able to be performed
- •4) Habitual use of opioid or steroid (excluding ointment, nasal spray, eye-drops)
- •5) A history of hypersensitivity to ramelteon
- •6) Currently receiving fluvoxamine
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