Safety and Efficacy of Fentanyl Versus Pethidine During Propofol-based Sedated Colonoscopy: Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Satisfaction of subjects
研究概览
简要总结
During sedative colonoscopy, use of propofol have been increased world wide. The onset time of propofol is shorter than midazolam. However the most popular additive pain killer, pethidine show different pharmacodynamic feature. The pethidine has longer onset time than propofol (nearly 30 minutes) and require more time to recovery. For this reason, the use of fentanyl has been increased world widely. However, exact comparison of pethidine and fentanyl was not studied. Therefore, we designed this study to compare both drug to check satisfaction of this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A patient who undergo screening colonoscopy with sedative agents
- •A patient over 20 years and under 65 years
- •A patient who agree to participate in this study
排除标准
- •A patient who is refered from outside hospital to remove previously noted colon polyp
- •The case who cannot be achieved cecal intubation because of poor bowel preparation
- •A patient who undergo sedative EGD just prior to colonoscopy
- •A patient who have allergy to propofol, pethidine, or fentanyl
- •A patient who have taken MAO inhibitor regularly
- •A patient who underwent colon resection surgery before colonoscopy
- •A patient who was diagnosed IBD before colonoscopy
- •Pregnant woman
- •A patient who cannot maintain sedation level because of significant cardiovascular disease, renal disease, pulmonary disease
- •A patient who do not agree to participate in this study
- •A patient who cannot understand this study because of foreigner or retarded mental status
- •A patient who have lower body weight, less than 37.5kg
研究组 & 干预措施
Fentanyl arm
The subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and fentanyl.
干预措施: fentanyl doses (Drug)
Pethidine arm
The subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and pethidine.
干预措施: pethidine dose (Drug)
结局指标
主要结局
Satisfaction of subjects
时间窗: 1 week later after colonoscopy
From previously reports, both pethidine and fentanyl are safe and effective agents for sedative colonoscopy. Therefore, we will check the subjects' satisfaction of procedure. If patients' satisfaction of procedure under one drug comparing to the others, we will select one drug as pain killer during colonoscopy.
次要结局
未报告次要终点