Investigation of the Effects of Intravenous Lidocaine Infusion During Sedation for Colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Consumption of propofol
研究概览
简要总结
This study assesses the benefits of continuous intravenous lidocaine administration during sedation for colonoscopy.
Sedation will consist of propofol infusion titrated to provide adequate working conditions to the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same volume of placebo (normal saline)
详细描述
The potential benefits of lidocaine infusion will be tested on:
- propofol consumption (primary outcome)
- intraoperative respiratory depression
- time for patient recovery
- postoperative fatigue
- postoperative pain
- postoperative cognitive dysfunction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- 是
入选标准
- •colonoscopy without gastroscopy
排除标准
- •lidocaine allergy
- •severe heart rhythm disorders
- •renal failure with creatinine clearance lower than 30ml/minute
研究组 & 干预措施
Lidocaine
Lidocaine. Administration of lidocaine is started with 1.5 mg/kg bolus injection followed by a continuous infusion of 4mg/kg/h.
干预措施: Lidocaine (Drug)
Placebo
Placebo Administration of normal saline: same volume of saline as lidocaine.
干预措施: normal saline (Drug)
结局指标
主要结局
Consumption of propofol
时间窗: intraoperative
Dose of propofol administered during sedation if measured at the end of it.
次要结局
- Episodes of oxygen desaturation(intraoperative)
- Time for recovery(intraoperative)
- Quality of working conditions assessed by the gastroenterologist(intraoperative)
- Abdominal discomfort(intraoperative and 15 minutes later)
- Postoperative fatigue(15 min after sedation)
- Cognitive condition(15 minutes after sedation)
研究者
Jean François Brichant
Professor and Chair
University of Liege