The Effect of Intravenous Lidocaine on the Time Course of Rocuronium Induced Neuromuscular Block. A Randomised, Placebo-controlled, Electrophysiological Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Onset and recovery of the neuromuscular block
研究概览
简要总结
Lidocaine is a local anesthetic which is widely used in daily anesthesia and surgical practice. It has been shown that intravenous lidocaine given during an operation has analgesic properties. Finally intravenous lidocaine is inexpensive and easy to administer and safe if non-toxic doses are respected. It is likely that the use of lidocaine infusions during anesthesia might increase in the coming years. Neuromuscular blockers (curare like substances) are used in anesthesia to facilitate tracheal intubation and to achieve muscle relaxation and immobility during surgery. Rocuronium is one of the most widely used neuromuscular blocking agents. Local anesthetics, such as lidocaine, are known to potentiate the effect of neuromuscular blocking agents. In the study the investigators want to evaluate the effect of intravenous lidocaine during the operation on the time course of the rocuronium-induced neuromuscular block. A secondary aim is to evaluate intubation conditions (lidocaine has been shown also to improve intubation conditions) and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult, age ≥18 to 60 years, male or female.
- •American Society of Anesthesiology [ASA] status I or II.
- •Patient is able to read and understand the information sheet and to sign and date the consent form.
- •Patient scheduled of elective surgery lasting longer than 120 min without need for continuous curarisation.
- •Surgery without application of local anesthetics (epidurals, wound-infiltration).
- •If the patient is female and of childbearing potential, she must have a negative pregnancy test.
排除标准
- •A history of allergy or hypersensitivity to rocuronium or lidocaine
- •Neuromuscular disease
- •Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics [aminoglycosides] and anticonvulsants [phenytoine])
- •Electrolyte abnormalities (for instance, hypermagnesemia)
- •Hepatic or renal insufficiency
- •Patients with epileptic disease
- •Patients with a body mass index <19 or >28 kg m2
- •Pregnant or breastfeeding women
- •Expected difficult intubation or mask ventilation
- •Atrioventricular heart block II or III -
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Lidocaine
干预措施: Lidocaine (Drug)
结局指标
主要结局
Onset and recovery of the neuromuscular block
时间窗: From start of injection of rocuronium until TOF 90%
次要结局
- To evaluate intubation conditions at T1, we will use the scale according to the Good Clinical Research practice (GRCP) in neuromuscular research(2 to 3 minutes)
- Any minor adverse event (no need for intervention) or major adverse event will be recorded.(up to 5 hours)