Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Calculating the the median effective dose (ED50) of ciprofol for sedation gastrointestinal endoscopy in obese patients.
研究概览
简要总结
Ciprofol is a new anesthetic, which combines with γ- Aminobutyric acid-a (GABAA) receptor. Ciprofol has shown equivalent anesthetic efficacy of propofol at 1/4 to 1/5 of the dosage. Ciprofol has the pharmacodynamic characteristics of rapid onset, stable and rapid recovery. Phase III clinical results showed that the incidence of injection pain and respiratory and circulatory depression of ciprofol was lower than that of propofol. Therefore, ciprofol has a good application prospect in sedation for gastrointestinal endoscopy, especially for obese patients. In the current study, we would explore the proper dose of Ciprofol in sedated gastrointestinal endoscopy in obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, ≤18 and ≤60 years, no gender limit
- •Undergoing routine gastrointestinal endoscopic diagnosis and treatment
- •American Society of Anesthesiologists (ASA) classification I-II
- •Body Mass Index(BMI) ≥28kg/m^2
- •Clearly understand and voluntarily participate in the study; provide signed informed consent
排除标准
- •Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)
- •Drug abuse history within 3 months before the screening period
- •People who are known to be allergic to eggs, bean products, opioids and other drugs, propofol, etc
- •The researcher believes that patients should not participate in this trial
研究组 & 干预措施
Ciprofol group
干预措施: ciprofol (Drug)
结局指标
主要结局
Calculating the the median effective dose (ED50) of ciprofol for sedation gastrointestinal endoscopy in obese patients.
时间窗: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
次要结局
- Calculating the the ED95 of ciprofol for sedation gastrointestinal endoscopy in obese patients.(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)