Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 334
- 试验地点
- 2
- 主要终点
- Propofol dose
研究概览
简要总结
Magnetic Endoscope Imaging (MEI) is an optional tool which can be switched on at the beginning of colonoscopy. MEI works by creating an electromagnetic field of very low intensity. By that the position of the endoscope can be displayed virtually on a monitor. The use of MEI has been shown to reduce the formation of loops and to ease the removal of existing loops during the investigation. Furthermore, as loops favour the occurrence of pain when the scope is moved forward, patients who underwent colonoscopy with MEI reported less pain at the end of the procedure.
Sedation is used widely during colonoscopy for it has improved the tolerability of the investigation. Most of the patients demand for sedation. In Germany Propofol is recommended as the first-line sedative when endoscopy it is performed in an outpatient setting. The use of Propofol involves the danger of respiratory complications. One reason for the application of Propofol doses is the occurrence of pain during the investigation. We hypothesized that if MEI is used and if loops can be avoided sufficiently lower Propofol doses would be needed. We therefore planned this prospective controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •medical indication for colonoscopy
- •age >18 years
- •written consent given by patient
- •investigation under sedation with propofol
排除标准
- •application of any other sedative than propofol
- •age < 18 years
- •pregnant women
- •patients denying written consent
- •ASA class IV, V and VI
- •indication for colonoscopy: emergency (e.g. severe rectal bleeding)
- •allergy to propofol
- •pre-existing hypotension, bradycardia or hypoxemia
- •history of sedation accidents
结局指标
主要结局
Propofol dose
时间窗: up to one day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)
At the end of colonoscopy total dose of Propofol applicated will be assessed.
次要结局
- Hypoxemia(up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day))
- Adenoma detection rate(up to one day)