Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation
研究概览
简要总结
Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for endoscopic retrograde cholangiopancreatography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (age 19~80 yrs, ASA Class I~III) who are scheduled for elective endoscopic retrograde cholangiopancreatograph
排除标准
- •Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Underlying renal (serum Cr >2mg/dL) or cardiac disease (NYHA class III or IV) Hypotension (SBP <90mmHg) or hypoxemia (SpO2 <90%) assessed prior to procedure
研究组 & 干预措施
Remimazolam
Patient group who receives remimazolam for sedation during endoscopy
干预措施: Remimazolam besylate (Drug)
Propofol
Patient group who receives propofol for sedation during endoscopy
干预措施: Propofol (Drug)
结局指标
主要结局
Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation
时间窗: Evaluation begins after sedative administration until the end of endoscopic procedure.
Incidence of Oxygen Reserve Index (ORI) drop to 0.00 will be evaluated after sedative administration, until the end of endoscopic procedure.
次要结局
未报告次要终点