Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- The overall complication rate
研究概览
简要总结
Providing the appropriate anesthetic technique for endoscopic retrograde cholangiopancreatography (ERCP) in remote locations can be challenging. The aim of this study was therefore to prospectively assess and compare the feasibility of monitored anesthesia care (MAC) with propofol based deep sedation, standard general anesthesia and general anesthesia without neuromuscular blockade in patients undergoing ERCP.
详细描述
ERCP is identified as one of the most invasive endoscopic procedures, during which patients may experience anxiety, discomfort and suffer different degree of pain. So, anesthesia and analgesia are essential for this invasive procedure, especially therapeutic ERCPs. Thus, we compared the efficacy of using monitored anesthesia care (MAC) with deep sedation versus general anesthesia (GA) to perform this procedure and the incidence of complications associated with these methods of anesthesia.
Previous studies have concluded that intubation is possible without the use of neuromuscular blockade. We assume that the use of propofol and adjuvants short-acting opioids may provide adequate conditions for tracheal intubation. It was also hypothesized that it may also be useful in facilitating ERCP under general anesthesia without neuromuscular blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years old
- •Grade Ⅰ and Ⅲ according to physical status classification system of the American Society of Anesthesiologists (ASA)
- •Coagulation function tests in normal range
排除标准
- •Potentially difficult airways
- •Administration of sedative or narcotic drugs in the previous 24 hours
- •Severe renal or hepatic impairment
- •Severe cardiopulmonary comorbidities (defined as American Society of Anesthesiologists physical status IV or greater)
- •Contraindications to a nasotracheal intubation
- •Coagulopathy
- •History of frequent episodes of epistaxis
- •Emergent ERCP
- •At risk for reflux and aspiration
结局指标
主要结局
The overall complication rate
时间窗: within 72 hours of ERCP
The primary outcome was the overall pulmonary and cardiac complication rate.
次要结局
- Premature termination rate of ERCP(During the procedure)
- Anesthesia time(During the procedure)
- Procedural failure rate of ERCP(During the procedure)
- Conversion to GA(During the procedure)
- Temporary interruption rate of ERCP(During the procedure)
- Procedure time(During the procedure)
- Delayed Adverse Events(within 72 hours of ERCP)
- Room time(During the procedure)
- Immediate Adverse Events(within 24 hours of ERCP)