Stellate Ganglion Blockade for the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of atrial fibrillation
研究概览
简要总结
The purpose of this study is to test if a nerve block procedure called a stellate ganglion block can help decrease the chance of atrial fibrillation after surgery. Atrial fibrillation is the abnormal, fast beating of the upper chambers of the heart. Stellate ganglion blockade has shown to decrease other types of abnormal heart rhythms as well as decrease the chance of atrial fibrillation.
详细描述
The investigator hypothesizes that stellate ganglion blockade with local anesthetic performed prior to cardiac surgery will reduce the incidence and duration of postoperative atrial fibrillation (POAF).
Specific Aim 1: Determine the incidence of POAF in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week.
Specific Aim 2: Determine the duration of POAF in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week.
Specific Aim 3: Determine the success rate of the block as evaluated by ipsilateral hand temperature change and skin sympathetic nerve activity (SKNA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.
- •Patients scheduled to undergo mitral or aortic valve surgery with or without coronary artery bypass grafting.
排除标准
- •Patients with a history of permanent atrial fibrillation, left or right ventricular assist device implantation or explantation.
- •Patients with procedures not requiring cardiopulmonary bypass.
- •Patients with procedures requiring deep hypothermic circulatory arrest.
- •Patients with active infection or sepsis.
- •Pre-operative immunosuppressive medication use (including steroid use).
- •Pre-operative anti-arrhythmic medication use (aside from beta-blockers).
- •Patients with Immunodeficiency syndrome.
- •Patients with known neurologic disorder.
- •Patients requiring left internal jugular central line placement.
- •Performance of Maze procedures or left atrial appendage ligation procedures will not exclude patients from potential enrollment as atrial fibrillation still occurs postoperatively while the scarring from the Maze procedure forms.
研究组 & 干预措施
Stellate ganglion block with local anesthetic
Subjects will receive a single injection of bupivacaine in a stellate ganglion block
干预措施: Stellate ganglion block (Procedure)
Stellate ganglion block with local anesthetic
Subjects will receive a single injection of bupivacaine in a stellate ganglion block
干预措施: Bupivacaine (Drug)
Stellate ganglion block with saline placebo
Subjects will receive a single injection of saline in a stellate ganglion block
干预措施: Stellate ganglion block (Procedure)
Stellate ganglion block with saline placebo
Subjects will receive a single injection of saline in a stellate ganglion block
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of atrial fibrillation
时间窗: Within one week of surgery or during hospitalization if discharged prior to one week
Percentage of subjects to experience postoperative atrial fibrillation (POAF)
次要结局
- Duration of atrial fibrillation(Within one week of surgery or during hospitalization if discharged prior to one week)
- Skin Sympathetic Nerve Activity(10-30 minute following performance of nerve block)
研究者
Erica D. Wittwer, M.D., Ph.D.
Principal Investigator
Mayo Clinic