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临床试验/NCT07077824
NCT07077824招募中不适用

Effect of Stellate Ganglion Block on Arterial Catheterization Complications in Selected Group of Patients Undergoing Elective Cardiac Surgeries

Ain Shams University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Incidence of arterial ischemia

研究概览

简要总结

Radial artery catheterization is the usual method for invasive monitoring in cardiac surgeries. Although it is relatively safe, complications do happen. Hematoma and ischemia are well known complications. Also, radial-to-femoral arterial pressure gradient (RFAPG) post bypass is a common event which affect management of a critical patient in a critical time. the study examines the effect of left stellate ganglion block (LSGB) on decreasing radial artery complications in cardiac surgeries

详细描述

Invasive blood monitoring is an essential prerequisite in all cardiac surgeries where the radial artery is the most common one used. It is easily accessible, apart from important nerves and has a well-known safe profile.

As perfection is an unattainable dream, radial artery complications do happen ranging from spasm, occlusion, hematoma formation and dissection Although incidence of ischemia post radial artery occlusion is not as common as the occlusion, serious effects do happen as reported digital necrosis and the need to do below elbow amputation in one case Patients undergoing cardiac surgeries usually suffers from many risk factors for Ischemic complications as risk of hypotension and use of vasoconstrictors The use of vasoconstrictors is more expected in patients with preoperative decreased Left Ventricle (LV) function (≤30%), moderate to severe Pulmonary Hypertension (PH), multiple procedures and prolonged bypass time.

Also, a complication that is relatively common in open heart surgeries is the central to radial artery pressure gradient that is usually encountered post bypass and may last for some time after and may affect up to 45% of patients in cardiac surgeries.

Usually the pressure gradient is for favor of the radial artery in awake patients due to the vascular resistance, but many theories tried to explain the cause of the opposed gradient post bypass. One theory related the issue to Vasoconstriction of the brachial artery.

Over the last few years, there were some studies, which investigated the effect of regional anesthesia techniques such as thoracic epidural anesthesia (TEA) and stellate ganglion block (SGB) for sympatholysis in cardiac surgeries The SGB with local anesthetics have been widely used to provide pain relief to treat vascular spastic disorders of upper limbs, chronic pain conditions and treatment of refractory angina The SGB has also been used for increasing radial artery (RA) blood flow and preventing RA spasm by sympathetic blockade in coronary artery bypass surgery In the current study, SGB will be studied regarding its effect in minimizing the occurrence of complications related to arterial catheterization in selected patients in cardiac surgeries.

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 (Participant, 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

入选标准

  • • Multiple procedures with expected prolonged bypass time (>100 min)
  • Moderate or severe Pulmonary hypertension

排除标准

  • • Patient not willing to participate in the study.
  • History of strokes / Transient ischaemic attacks
  • History of Glaucoma.
  • History of allergy to local anaesthetic drugs.
  • Pre-existing contralateral phrenic nerve palsy.
  • Patients with existing coagulopathy.

结局指标

主要结局

Incidence of arterial ischemia

时间窗: from end of surgery till hospital discharge aproximately one week

Incidence of arterial ischemia in form of colour changes and confirmed by arterial duplex

次要结局

  • • Incidence of radial to femoral artery pressure gradient(from weaning from cardiopulmonary bypass till transferal to icu aproximately 1-2 hours)

研究者

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

abdallah mahmoud zaki soudi

Dr.

Ain Shams University

研究点 (2)

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