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临床试验/NCT03450226
NCT03450226Unknown不适用

Effects of Stellate Ganglion Block on Hemodynamics Instability During Beating Heart Surgery

Assiut University0 个研究点目标入组 40 人开始时间: 2018年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
主要终点
postoperative electrocardiogram changes

研究概览

简要总结

studies suggest that off-pump coronary artery bypass surgery is associated with improved outcomes when compared to on-pump coronary artery bypass. many studies have shown that off-pump coronary bypass surgery reduces patient morbidity and mortality.

manipulation of the coronary arteries during cardiac surgery can stimulate the adjacent post-ganglionic sympathetic fibers and mimic stellate ganglion stimulation ,stellate ganglion block (SGB) can interrupt this reflex by decreasing the efferent cervical sympathetic outflows.

详细描述

when adopting off-pump surgery , the cardiac surgery team must adopt new techniques to handle a beating heart and the variations in hemodynamics that can occur when performing this type of procedure the incidence rate of cardiac arrhythmia occurring during and after surgery is one of the major complication in open heart surgery. in addition , intraoperative hemodynamic disorders, caused by changes in plasma levels of epinephrine and norepinephrine after surgical stimulation , are some of challenges for patients undergoing off-pump coronary artery bypass surgery. hemodynamic disruption leads to myocardial ischemia, resulting in increased incidence of cardiovascular events and mortality.

stellate ganglion is formed by the fusion of inferior cervical and first thoracic sympathetic ganglia and is located behind the subclavian artery and anterior to the first rib. the inferior cervical cardiac nerves arise from the medial aspect of the stellate ganglia and provide the cardio-accelerator nerve fibers to the cardiac plexus. stellate ganglion stimulation augments peak systolic pressure, and the enhanced myocardial contractility is secondary to stimulation by postganglionic nerve fibers which traverse from stellate ganglion down the great vessels and along the coronary arteries into the myocardium.the blockage of inferior cervical cardiac nerves is responsible for the bradycardia seen following SGB. SGB has been shown to prevent and control perioperative hypertension induced by increased sympathetic activity.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing elective off-pump coronary artery bypass grafting surgery
  • patients with an ejection fraction of more than 50%
  • creatinine level of less than 2.0 mg / 100 ml
  • no evidence of heart failure
  • no significant chronic obstructive lung disease
  • age of less than 60 years

排除标准

  • emergency surgery
  • patients on thrombolytic therapy
  • patients with coagulation disorders
  • patients requiring heart lung machine
  • patients with clinical contraindications to SGB ( including allergy to local anesthetic , carotid vascular disease as defined by ipsilateral prior carotid endarterectomy or carotid stent, superficial infection at the proposed puncture site, contralateral phrenic or laryngeal nerve palsies , and severe chronic obstructive pulmonary disease )
  • patients with history of atrial fibrillation

研究组 & 干预措施

treatment

Experimental

patients will receive a stellate ganglion block with 10 ml of 0.25 % bupivacaine

干预措施: stellate ganglion block (Drug)

结局指标

主要结局

postoperative electrocardiogram changes

时间窗: up to 7 days

absence of new onset postoperative cardiac arrhythmia and myocardial infarction after off-pump coronary artery bypass surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

sara abdallah

doctor

Assiut University

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