Effect of Intravenous Lidocaine, Used to Attenuate Pain With Propofol Injection, on Defibrillation Threshold Testing
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Incidence of successful defibrillation on first attempt with 10-12 joules.
研究概览
简要总结
The use of lidocaine, as an anesthetic drug, during implantation of an implantable cardioverter-defibrillator(ICD)will not result in a clinically significant alteration of the defibrillation threshold during ICD placement.
详细描述
Summary: The purpose is to observe the incidence of successful defibrillation on the first attempt during implantation of an implantable cardioverter-defibrillator (ICD) among patients who receive a standard dose of intravenous lidocaine (for attenuation of pain associated with propofol injection) versus patients who do not receive an intravenous lidocaine dose.
During implantation of an ICD, defibrillation threshold (DFT) testing is performed. DFT is calibrated as the lowest energy delivered by the ICD that will successfully terminate malignant arrhythmia. Lidocaine, a routine anesthetic agent, is also identified as an antiarrhythmic drug. Experimentally, lidocaine has been shown to increase thresholds during DFT' testing due to the drugs dual effect. The rationale behind this project is that the lidocaine may yield falsely elevated DFT, resulting in higher calibration of the ICD device. This alteration can affect ICD battery and overall ICD life. Comparisons between study groups may elucidate effects of IV lidocaine on DFT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Any person referred to the Hahnemann University Hospital Electrophysiology Laboratory for a clinically indicated ICD implant
排除标准
- •Any person under the age of 18 years
- •Inability to give an informed consent
- •Allergy to lidocaine
- •Receiving lidocaine treatment for pain or arrhythmia
- •Contraindication for DFT testing
- •Not consenting for DFT testing
- •Receiving energy other than 10-12.5 joules as initial DFT test
- •Implant of ICD on the right side
- •DFT not planned to be performed during ICD implant
- •Epicardial placement of ICD leads
- •Use of single coil ICD lead
- •Subpectoral ICD implantation
- •Cephalic cutdown used for central venous access
- •Require more than 3mg/kg of 1% SQ lidocaine for local anesthesia
- •Pregnant women or prisoners
研究组 & 干预措施
Lidocaine
treatment arm
干预措施: lidocaine (Drug)
Saline
placebo arm
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of successful defibrillation on first attempt with 10-12 joules.
时间窗: Through study completion but no longer than 1 year
These patients will receive a standard dose of intravenous lidocaine (for attenuation of pain associated with propofol injection) versus patients who do not receive an intravenous lidocaine dose. Outcome is to have a success defibrillation within the first attempt.
次要结局
- Incidence of failure to defibrillate at higher energy levels.(Through study completion but no longer than 1 year)
- Defibrillation threshold (DFT) for subjects who fail to defibrillate at the initial 10-12 joules.(Through study completion but no longer than 1 year)