Effect of Anesthesia on Force Application During Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Peak push force is increased in patients receiving propofol as compared to conscious sedation.
研究概览
简要总结
The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.
详细描述
Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age: 30-75 years
- •ASA Class I or II
- •All ethnic and racial groups will be included
排除标准
- •Colonic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor.
- •Specific pathology that would limit the extent of examination
- •ASA class 3 or greater
- •Pregnancy
- •Monitored anesthesia using propofol for sedation.
- •Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity
结局指标
主要结局
Peak push force is increased in patients receiving propofol as compared to conscious sedation.
时间窗: 6 months
次要结局
未报告次要终点