Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Satisfaction scores by endoscopist
研究概览
简要总结
The aim of this study is to compare sedation efficiency, safety and satisfaction by both endoscopist, assistants, and the patients between continuous infusion and intermittent bolus injection of propofol for deep sedation during ERCP.
详细描述
The patients undergone ERCP were randomly assigned to either continuous infusion of propofol (continuous group) or midazolam plus intermittent bolus injection of propofol (intermittent group) for deep sedation. In the continuous group, propofol was continuously administered via infusion pump and the doses were determined by sedation assistants monitoring the patients. In the intermittent group, a loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol was initially injected and repeated bolus injection of 20 mg of propofol was followed according to patients' sedation level. Sedation related parameters (total dose of propofol, induction/recovery time, patients' cooperation) and adverse events during the procedure were evaluated. Satisfaction scores by endoscopist, assistant, and patients and difficulty scores of maintaining the sedation by assistants were also graded after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergone ERCP for biliary and pancreatic diseases
排除标准
- •Comorbid conditions of ASA class 4-5
- •Age under 18 years or over 90 years
- •Pregnancy
- •Past medication history of benzodiazepine or narcotics
- •Known allergy to midazolam or propofol
- •hypotension (systolic blood pressure <90 mmHg), hypoxemia (SaO2 <90%), or bradycardia (50/min) at baseline measurements
研究组 & 干预措施
Intermittent bolus injection of propofol
A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
干预措施: Intermittent bolus injection of propofol (Procedure)
Intermittent bolus injection of propofol
A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
干预措施: Midazolam (Drug)
Intermittent bolus injection of propofol
A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
干预措施: Propofol (Drug)
Continuous infusion of propofol
Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
干预措施: Continuous infusion of propofol (Procedure)
Continuous infusion of propofol
Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
干预措施: Propofol (Drug)
结局指标
主要结局
Satisfaction scores by endoscopist
时间窗: 30 minutes after the procedure
次要结局
- Adverse events for sedation(1 day after the procedure)
- Difficulty scores of maintaining the sedation(30 minutes after the procedure)
研究者
Kyo-Sang Yoo
Professor
Hanyang University