Efficacy of Intravenous Infusion of Lidocaine in Sedation for ERCP: a Randomised Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- the incidence of bucking during the procedure
研究概览
简要总结
Intravenous infusion of lidocaine significantly reduces incidence of bucking when perfomed gastroscopy.
详细描述
This study divide patients into two groups, the patients in lidocaine group will be given lidocaine; the control group will be given placebo .the primary endopiont was to investigate whether intravenous lidocaine can reduce incidence of bucking and movement in sedation of gastroscopy.
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
- •patients aged >18 years who were scheduled for ERCP 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
the incidence of bucking during the procedure
时间窗: half a year
the difference between incidence of bucking of the two groups
次要结局
- propofol consumption difference between the two groups(half a year)
- the incidence of infusion pain when adminstrated propofol(half a year)
- Safety assessed by the rate of hypoxia during the procedure(half a year)
- Safety assessed by the rate of hypotention during the procedure(half a year)
- Safety assessed by the rate of breadycardia during the procedure(half a year)
- Safety assessed by the rate of required airway management during the procedure(half a year)
- endoscopists satisfaction assessed by the performer(half a year)
- patient satisfaction assessed by the patient(half a year)
- anesthetist satisfaction(half a year)
- pain socre after the gastroscopy(half a year)
- fatigue score after the ERCP(half a year)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University