The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- atrial fibrillation
研究概览
简要总结
This study is being done to determine if lidocaine, administered during surgery and for 24 hours after surgery can reduce inflammation, thereby reducing the risk of atrial fibrillation and 30 day mortality after surgery. Participants undergoing cardiac surgery will be randomized to receive either lidocaine or placebo.
详细描述
Subjects undergoing cardiac surgery are randomized into one of two groups.
- Group 1: Intravenous Lidocaine Group
- Group 2: Intravenous placebo Group
Either Lidocaine or placebo is administered throughout surgery and 24 hours after surgery.
Patients in both groups will undergo quality of life assessments and functional recovery assessments post-surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90 years old
- •Scheduled for cardiac surgery requiring cardiopulmonary bypass
- •Written informed consent
排除标准
- •Off-pump surgical procedures
- •Anticipated deep hypothermic circulatory arrest
- •Any contraindications to the proposed interventions including lidocaine allergy
- •History of preoperative atrial fibrillation
- •Baseline Screening revealing preexisting dementia or delirium
- •Preoperative liver failure defined as Child-Pugh Score > 6
研究组 & 干预措施
1
Intravenous Lidocaine group
干预措施: Lidocaine (Drug)
Placebo
Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
干预措施: Placebo (Other)
结局指标
主要结局
atrial fibrillation
时间窗: postoperatively
To test the hypothesis that lidocaine infusion started at induction of anesthesia and maintained for 24 hours postoperatively will decrease the incidence of atrial fibrillation compared to an intravenous saline control.
mortality
时间窗: 30 days post surgery
To test the hypothesis that lidocaine infusion started at induction of anesthesia and maintained for 24 hours postoperatively will decrease the incidence of 30 day mortality as compared to an intravenous saline control.
次要结局
未报告次要终点