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临床试验/NCT05952011
NCT05952011已完成不适用

Effect of Stellate Ganglion Block on Internal Mammary Artery Dynamics

Ain Shams University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年8月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Effect of left stellate ganglion block on the left internal mammary artery blood flow after 10 minutes

研究概览

简要总结

This study aims to assess the effect of a stellate ganglion block on the flow and diameter of the internal mammary artery using the pulsatility index and transient time flowmetry(TTFM) in patients undergoing coronary artery bypass grafting.

详细描述

The internal mammary artery (IMA) is the preferred graft for myocardial revascularization because of its superiority over venous grafts owing to long term patency, lower mortality rates and improved post-operative outcomes.

However, conduit spasm is a recognized complication of coronary artery bypass surgery mainly affecting the arterial conduits, a major concern that can lead to acute myocardial ischemia and may contribute to reduce graft patency.

Topical application or systemic administration of many pharmacological agents has been shown to reverse or prevent graft spasm, but side effects are reported with the use of these agents.

Various vasodilators that have been tried included various organic nitrates, calcium channel blockers, sodium nitroprusside (SNP) and papaverine.

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 and studied its effects on internal mammary artery diameter .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 to 65 years.
  • Patients who will be slated to undergo elective coronary artery bypass graft surgery under Cardiopulmonary bypass in the Department of Cardiothoracic Surgery.

排除标准

  • Patient not willing to participate in the study.
  • Age more than 65 years.
  • Ejection fraction < 45%.
  • History of strokes / Transient ischaemic attacks and vertebro basilar insufficiency
  • History of Glaucoma.
  • History of allergy to local anaesthetic drugs.
  • Emergency coronary artery bypass graft or reoperations.
  • Pre-existing contralateral phrenic nerve palsy.
  • Patients with existing coagulopathy.
  • Allergy to nitroglycerin.

研究组 & 干预措施

The first group (A) Stellate Ganglion Block Group

Experimental

Participants in this group will receive a left stellate ganglion block (LSGB) preoperatively. The IMA pulsatility index and diameter will be measured before and after the stellate ganglion block and during both the preoperative and the intraoperative periods. Transit-time flowmetry (TTFM) will be used intraoperatively to assess IMA flow.

干预措施: Left stellate ganglion block (Procedure)

The first group (A) Stellate Ganglion Block Group

Experimental

Participants in this group will receive a left stellate ganglion block (LSGB) preoperatively. The IMA pulsatility index and diameter will be measured before and after the stellate ganglion block and during both the preoperative and the intraoperative periods. Transit-time flowmetry (TTFM) will be used intraoperatively to assess IMA flow.

干预措施: Topical Nitroglycerine (Drug)

The second Group (B) Control Group (No left stellate ganglion block LSGB)

Active Comparator

Participants in this group will not receive a stellate ganglion block. The IMA pulsatility index and diameter will be measured before and after the stellate ganglion block and during both the preoperative and the intraoperative periods. Transit-time flowmetry (TTFM) will be used intraoperatively to assess IMA flow. Topical nitroglycerin will also be applied intraoperatively, similar to the SGB group.

干预措施: Topical Nitroglycerine (Drug)

结局指标

主要结局

Effect of left stellate ganglion block on the left internal mammary artery blood flow after 10 minutes

时间窗: 10 minutes after the left Stellate Ganglion Block

LIMA blood flow will be measured using the pulsatility index

次要结局

  • Change in Left Internal Mammary Artery (LIMA) diameter after left Stellate Ganglion Block(10 minutes after block)
  • Effect of left stellate ganglion block on the left internal mammary artery blood flow after cardiopulmonary bypass(After cardiopulmonary bypass)
  • Effect of left stellate ganglion block on mean blood pressure (MBP)(During surgery: baseline, after induction of anesthesia, at time after skin incision, after sternotomy, before and after cardiopulmonary bypass (CPB), after protamine and at the end of operation)
  • Effect of left stellate ganglion block on heart rate (HR))(During surgery: baseline, after induction of anesthesia, at time after skin incision, after sternotomy, before and after cardiopulmonary bypass (CPB), after protamine and at the end of operation)

研究者

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

Diaaeldin Badr Aboelnile

Lecturer of Anesthesia

Ain Shams University

研究点 (1)

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