Efficacy of Intravenous Infusion of Lidocaine in Sedation for Colonoscopy: a Randomised Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- fatigue score after colonoscopy
研究概览
简要总结
intravenous infusion of lidocaine significantly reduce fatigue and pain and improve the patients satisfaction after sedation for colonoscopy.
详细描述
This study divide patients into two groups, lidocaine group one will be given lidocaine intravenously; control group will be given saline . the difference between patients fatigue and pain will be compared. and the propofol consumption, pain after infusion of propofol, patients, endoscopists and anaesthesist satifaction, the incidence of hypotenstion, hypoxia, and bradycardia will aslo be compared between the two groups.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria: patients aged >18 years who were scheduled for colonscopy at Qilu hospital.
排除标准
- •patients with ASA (American Society of Anesthesiologists) Class 4 or 5, pre-existing hypoxemia (SpO2 <90%), hypotension (systolic blood pressure <90 mm Hg), bradycardia (HR<50 beats/min), uncontrolled hypertension (SBP >170 mm Hg, diastolic blood pressure>100 mm Hg), severe renal or liver failure, pregnancy or lactation, allergy to lidocaine, atrioventricular block, epilepsy, and inability to give informed consen
研究组 & 干预措施
control group
the control group will be given the same volume of saline as the experimental group
干预措施: placebo (Drug)
lidocaine group
the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h
干预措施: lidocaine (Drug)
结局指标
主要结局
fatigue score after colonoscopy
时间窗: half a year
fatigue were measured on a 0-10VAS at arrival in the recovery room ,30min later
次要结局
- pain socre after colonoscopy(half a year)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University