Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- total dose of propofol
研究概览
简要总结
The purpose of this study is to determine whether a non-pharmacological intervention reduces consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce side effects. This non-pharmacological intervention may increase patient's comfort and security.
详细描述
Sedative and analgesic drugs are used in most patients related to pain and anxiety during the colonoscopy. Analgesia and sedation has adverse effects such as central respiratory depression, obstruction of the upper airways, hypoxia, hypotension and bradycardia. Non-pharmacological interventions had beneficial effects during percutaneous vascular or renal procedures. In this study we test the hypothesis that the adjunction of hypnosis to pharmacological sedation will decrease the quantity of sedative drugs used and will reduce the patient's anxiety and discomfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients classified as ASA 1 to 3
- •colonoscopy with anesthesiological support
- •capacity of consenting
排除标准
- •pregnancy
- •colonoscopy with gastroscopy
- •emergency
- •psychotic diseases
- •incapacity to understand french
- •addiction of drugs and alcohol
- •psychoactive drugs
研究组 & 干预措施
standard sedation
propofol and fentanyl
干预措施: standard sedation (Drug)
structured attention-standard sedation
structured attention
干预措施: Structured attention (Behavioral)
hypnosis-standard sedation
hypnosis
干预措施: hypnosis (Behavioral)
结局指标
主要结局
total dose of propofol
时间窗: the day of the colonoscopy, at the end
次要结局
- gastroenterologist's satisfaction and quality of the colonoscopy(the day of the procedure, at the end of the procedure)
- vital parameters(during all the procedure, every 5 minutes)
- patient's comfort(during the procedure every 10 minutes and 1 and 14 days after the colonoscopy)
- anxiety state(between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after the end of the procedure)
- patient's satisfaction(between 5 minutes to 1 hour after the end of the procedure and 1 and 14 days after the colonoscopy)
- duration of the procedure(the day of the procedure)
研究者
Cheseaux Nicole
MD
University Hospital, Geneva