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临床试验/NCT05932485
NCT05932485已完成不适用

Effect of Stellate Ganglion Block on New Atrial Fibrillation After Coronary Artery Bypass Grafting

Yangzhou University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
1
主要终点
The occurrence of new atrial fibrillation was detected by ECG monitoring

研究概览

简要总结

Post-operative new-onset atrial fibrillation (POAF) is one of the most common arrhythmias in adults after direct intracardiac surgery with extracorporeal circulation. The incidence of POAF in coronary artery bypass grafting (CABG) is approximately 30%. POAF can lead to an increased risk of complications such as stroke, heart failure, and acute kidney injury, which not only prolongs the patient's hospital stay, but also increases hospital costs and mortality. operation, extracorporeal circulation, and the patient's underlying conditions (such as age, gender, hypertension, and diabetes), which cause sympathetic activation, inflammatory response, and myocardial ischemia in the organism. The stellate ganglion block (SGB) regulates the sympathetic tone of the innervated nerves and thus the autonomic function of the body. SGB can effectively regulate the sympathetic-parasympathetic imbalance. Also, SGB may exert some anti-inflammatory effects. In this study, ultrasound-guided SGB was used in CABG patients to investigate its effect on the occurrence of POAF.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing first-time and elective coronary artery bypass grafting;
  • ASA grade II-IV;
  • The preoperative ECG showed sinus heart rate.

排除标准

  • The patient refused to participate in this study;
  • Surgical procedures include any other type of heart surgery in addition to CABG;
  • Allergic to known general anesthesia drugs;
  • Patients with a history of neck surgery or abnormal neck anatomy;
  • Patients with contraindications to SGB.

结局指标

主要结局

The occurrence of new atrial fibrillation was detected by ECG monitoring

时间窗: Within 5 days after surgery

ECG monitor shows atrial fibrillation. To be specific: 1)Irregular R-R interval (when atrioventricular conduction is present), 2) P wave disappearance, 3) irregular atrial activity.

次要结局

  • AF burden(within 5 days after surgery)
  • Duration of the first episode of POAF(within 5 days after surgery)
  • Need for Antiarrhythmic treatments(within 5 days after the operation)
  • the concentration of interleukin-6(end of surgery, 24 hour postoperatively, 72hour postoperatively, 5 day postoperatively)
  • Changes of intraoperative Left ventricular diastolic function(T1 (after sternotomy and before CPB) and T2 (30 minute after CPB cessation).)
  • the concentration of CRP(end of surgery,24 hour postoperatively ,72 hour postoperatively ,5 day postoperatively)
  • the concentration of Hs-cTnT(end of surgery, 24hour postoperatively, 72hour postoperatively)
  • the concentration of CK-MB(end of surgery, 24hour postoperatively, 72hour postoperatively)
  • postoperative adverse reactions(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)

研究者

发起方
Yangzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhuan Zhang

MD, the Deputy Director of Anesthesiology, the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou University

研究点 (1)

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