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临床试验/NCT04439760
NCT04439760已完成不适用

Efficacy of Superior Cervical Ganglion (SCG) Block on the Incidence and Severity of Vasospasm After Middle Cerebral Artery (MCA)Aneurysmal Surgery Using Transcranial Doppler(TCD). A Randomized Controlled Trial.

Fatma Ibrahim El Sayed Salman1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年10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
36
试验地点
1
主要终点
Change from baseline Blood flow velocity in middle cerebral artery measured by transcranial doppler (TCD)

研究概览

简要总结

The aim of this study is to assess blood flow velocity in middle cerebral artery measured by transcranial doppler to determine the efficacy of SCG block in decreasing incidence or severity of vasospasm after MCA aneurysm surgery.

详细描述

Sympathetic innervation to the face and head is by superior cervical ganglion(SCG), which is the most cranial part of the sympathetic chain. It is suited in a plication of the prevertebral fascia anterior to the longuscapitis muscle and dorsal to the internal carotid artery, posteromedial to the vagus nerve at c3 level. It's mainly located at the level of the transverse processes of the second and third cervical vertebrae. However, it may reach caudally to the upper border of the fourth cervical vertebra.

Noradrenergic sympathetic nerve fibers mainly originating in the superior cervical ganglion, accompanying the carotid artery supply cerebral vasculature particularly the pial vessels.

Superior cervical ganglion block was previously tried in managing neuropathic pain, neuropathic pain in head and face region was investigated in patients using ganglionic local opioid analgesia (GLOA) at the superior cervical ganglion (SCG) ,The short-term analgesic effect of the first blockade by GLOA was significant with a mean pain reduction of 52% (p < 0.001).

Superior cervical ganglion block also used as an alternative treatment to tinnitus not responding to conventional therapy, it increases cholear blood flow and this can explain the efficacy of block.

Superior cervical ganglion block was used to improve cerebral perfusion in patients with cerebral vasospasm after aSAH.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 18 to 70 years.
  • Genders eligible for study: both sexes.
  • ASA I-II.
  • GCS (13-15)

排除标准

  • Patient refusal
  • Contraindications to regional anesthesia (Bleeding disorders, Use of any anti-coagulants, local infection).
  • Known allergy to local anesthetics.
  • ASA III-IV.
  • Patients aged less than 18 or more than 70.

结局指标

主要结局

Change from baseline Blood flow velocity in middle cerebral artery measured by transcranial doppler (TCD)

时间窗: The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 & TCD7)

Change in Blood flow velocity in patients with ruptured aneurysmal subarachnoid hemorrhage undergoing MCA aneurysmal surgeries measured by transcranial doppler

次要结局

  • Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression).(within 14 days)
  • Glasgow coma scale(Baseline (Preopetative), at day 3 and day 7)
  • Change from baseline heart rate(Baseline (Before surgery) ,after induction the block and at the end of surgery)
  • Change from baseline mean arterial blood pressure(Baseline (Before surgery) ,after induction the block and at the end of surgery)
  • Incidence or severity of MCA postoperative spasm over 14 days.(within 14 days)
  • Change from baseline oxygen saturation (Sao2)(Baseline (Before surgery) ,after induction the block and at the end of surgery)

研究者

发起方
Fatma Ibrahim El Sayed Salman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatma Ibrahim El Sayed Salman

anesthesia assistant lecturer

Kasr El Aini Hospital

研究点 (1)

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