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
- 40
- 试验地点
- 2
- 主要终点
- propofol consumption difference between the two groups
研究概览
简要总结
Intravenous infusion of lidocaine significantly reduces propofol dose for ERCP and improve patients' recovery after ERCP.
详细描述
This study divide patients into two groups, one will be given lidocaine; another group was given placebo . to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inpatients aged >18 years who were scheduled for ERCP at Qilu hospital.
排除标准
- •Patients with ASA class 4 or 5,
- •Patients with pre-existing hypoxaemia (SpO2<90%),
- •Patients with hypotension (SBP<90mmHg)
- •Patients with bradycardia (HR<50 bpm)
- •patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- •patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- •patients with pregnancy or lactation
- •Patients hemodynamically unstable
- •Patients unable to give informed consent
- •Patients with a history of drug allergies;
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)
Experimental: 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
propofol consumption difference between the two groups
时间窗: half a year
the total propofol dosage consumption between the two groups
次要结局
- Safety assessed by the rate of hypoxia during the procedure 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)
- endoscopists satisfaction assessed by the performer(half a year)
- patient satisfaction assessed by the patient(half a year)
- pain socre after the ERCP(half a year)
- fatigue score after the ERCP(half a year)
- Safety assessed by the rate of required airway management 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 involuntary movement during the procedure(half a year)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University