Lidocaine Continuous Infusion for ERCP Procedures: a Prospective, Randomized, Double-blinded, Controlled Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Propofol consumption between the 2 groups
研究概览
简要总结
This study aims to investigate the dose reduction of propofol if associated with continuous infusion of lidocaine during ERCP procedures in patients over 65 years old.
详细描述
The primary aim of this study was to evaluate the effect of continuous infusion of lidocaine on propofol consumption in older patients having ERCP sedation. Secondary outcomes were to evaluate patient adverse events, sedation quality and satisfaction of the patient and the endoscopist, postprocedural pain, and sedation-related time.For this the investigators randomised patients into 2 groups: Group Lidocaine received 1,5 mg/kg lidocaine 1% 10 min before procedure and then 2 mg/kg/h continuous infusion of lidocaine 1%, whereas the Group Control received an equal volume of saline solution, which could not be visually identified from lidocaine by the blinded anaesthesiologist. All patients received propofol bolus dose of 1mg/kg than 10-20 mg iv boluses during the procedure guided by capnograph monitoring and the patient's grimace, mobility, hemodynamic changes.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients, endoscopist, anesthetist, and data collection observers were all blinded to the group allocation.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65-85 years old
- •physical status ASA I, II, III,
- •ERCP scheduled
排除标准
- •ASA IV or higher
- •severe renal, cardiac or liver failure,
- •allergy to lidocaine,
- •patients weighing less than 40 kg,
- •inability to give informed consent
研究组 & 干预措施
Group Placebo
the control group will be given the same volume of saline as the experimental group
干预措施: Placebo (Drug)
Group Lidocaine
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 between the 2 groups
时间窗: During ERCP procedure
To evaluate propofol consumption by recording total dose of propofol(mg) during ERCP procedure between the 2 groups.
次要结局
- Safety assessed by the rate of hypoxia during the procedure(During ERCP procedure)
- Safety assessed by the rate of involuntary movement during the procedure(During ERCP procedure)
- Lidocaine(During ERCP procedure)
- Endoscopist satisfaction between 2 groups(After ERCP procedure)
研究者
Breazu Caius Mihai
Assistant Professor MD PhD
Iuliu Hatieganu University of Medicine and Pharmacy