JPRN-jRCT2031200360已完成2 期
A Phase II/III Investigator Initiated Clinical Traial Evaluating the Efficacy and Safety of Remimazolam in Japanese Patients Undergoing Gastrointestinal Endoscopy
Ikehara Hisatomo0 个研究点目标入组 150 人开始时间: 2021年2月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Dose-finding step
- •1The age at the time of obtaining consent is 20 to 74 years old
- •2 ASA classification is I or II
- •3 Weight 45kg or more and 70kg or less, BMI less than 30
- •Verification step
- •1 The age at the time of obtaining consent is 20 years or older
- •2 BMI is less than 30
排除标准
- •Dose-finding step and verification step
- •1 Alcohol polydipsia (60g or more per day in terms of pure alcohol)
- •2 Those who regularly use benzodiazepines
- •3 Those who regularly use analgesics
- •4 Those with severe mental disease
- •5 Those with a history of abdominal surgery
- •6 Those with severe respiratory disease
- •7 SpO2 95% (room air)
- •8 Mallampati classification III or higher
- •9 Those with essential hypotension
- •10 Among the clinical test measurement values at the time of screening, those that correspond to any of the following
- •AST value: 2.5 times or more of the facility standard value upper limit
- •ALT value: 2.5 times or more of the upper limit of the facility standard value
- •Total bilirubin value: 1.5 times or more of the upper limit of facility standard value
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