NCT07271615已完成不适用
Preoperative Stellate Ganglion Block Reduce the Incidence of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Prospective, Randomized Controlled Pilot Trial
Xijing Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月19日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- postoperative atrial fibrillation（POAF）
研究概览
简要总结
The primary objective of this study is to determine the feasibility of preoperative stellate ganglion block in reducing the incidence of postoperative atrial fibrillation in patients undergoing CABG.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than 18 years old
- •undergoing CABG
- •Provide informed consent
排除标准
- •History of prior cardiac surgery or atrial fibrillation ablation;
- •Emergency coronary artery bypass grafting (CABG);
- •Concomitant cardiac procedures (e.g., congenital heart disease repair, left ventricular reconstruction, valve surgery, or aortic surgery);
- •Critical preoperative status requiring mechanical or pharmacological support before CABG;
- •Left ventricular ejection fraction (LVEF) <35%;
- •History of atrial fibrillation (defined as a supraventricular tachyarrhythmia characterized by rapid and irregular atrial electrical activity);
- •Significant mitral valve disease (mitral valve area <1.5 cm² or regurgitant jet area <4 cm²), significant aortic valve disease (valve area <1.5 cm² or regurgitant jet-to-left ventricular outflow tract ratio >25%);
- •Severe left atrial enlargement (left atrial anteroposterior diameter >55 mm);
- •Poorly controlled hyperthyroidism;
- •Conditions requiring radiotherapy, chemotherapy, or long-term hormonal therapy;
- •Patients with known clinical contraindications to stellate ganglion block (SGB).
研究组 & 干预措施
Stellate Ganglion Block（S group）
Other
Ultrasound-guided stellate ganglion block with ropivacaine
干预措施: Stellate Ganglion Block (Procedure)
Control group（C group）
No Intervention
the best available treatment without block (usual care)
结局指标
主要结局
postoperative atrial fibrillation（POAF）
时间窗: within 7 days postoperatively
次要结局
- the duration of postoperative in-hospital stay(duration of postoperative hospital stay)
- cumulative time spent in postoperative atrial fibrillation(within 7 days postoperatively)
- the need for antiarrhythmic medications to treat postoperative atrial fibrillation(within 7 days postoperatively)
- the need for systemic anticoagulation due to postoperative atrial fibrillation(within 7 days postoperatively)
- the need for postoperative electrical cardioversion(within 7 days postoperatively)
- number of POAF(within 7 days postoperatively)
研究者
Chong Lei, MD & phD
MD，phD
Xijing Hospital
研究点 (2)
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