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Completed

NCT Number: NCT04100824

Stellate Ganglion Block as Adjuvant Therapy to ca Channel Blocker

Aim of work:

To evaluate the effect of stellate ganglion block in prevention of cerebrovascular spasm in traumatic subarachnoid hemorrhage Primary outcome: Asses changes of cerebral blood flow velocity by Trans cranial Doppler.

Secondary outcome: Asses changes in clinical status

Completed

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Key information

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ِAssiut University Hospital

Asyut, 1111111, Egypt

About this study

A subarachnoid hemorrhage is a relatively uncommon type of stroke incidence and impact of traumatic brain injury hemorrhage (aSAH) has been extensively studied; less is (TBI) within the general population have increased known regarding the epidemiology of posttraumatic passover the past few years . It accounts for about 1 in 20 (5%) of all strokes. In contrast to common types of stroke, subarachnoid hemorrhage often occurs at a relatively young age half the patients are younger than 60 years. The outcome of patients after subarachnoid hemorrhage is generally poor. One of the causes of poor outcome is due to spasm and lack of blood supply to brain this occurs four to ten days after the hemorrhage.

Calcium antagonists as nimodipine are a type of drug that block calcium channels in cells and are often used for the treatment of high blood pressure. They have also been shown to counteract the narrowing of blood vessels after subarachnoid hemorrhage. Nimodipine is a dihydropyridine agent that blocks voltage-gated calcium channels and has a dilatory effect on arterial smooth muscle. It is the only FDA-approved agent for vasospasm with a half-life of about 9 h . Its beneficial effect on CVS derives most likely from its neuroprotective properties compared to arterial smooth muscle cell relaxation . The investigators can give nimodipine in several way as oral or IV and intrathecal .

Stellate ganglion block (SGB) has an established use in treating patients with disorders mediated by the sympathetic nervous system in which pain and/or circulatory insufficiency are predominant symptoms. These disorders include Atypical angina , post-herpetic neuralgia and complex regional pain syndromes, such as reflex sympathetic dystrophy .In addition, SGB has also been used, albeit somewhat controversially, in management of traumatic brain edema, schizophrenia, and complicated cervical migraine. However, the use of cervical sympathetic block has been described in reversing delayed ischemic neurologic deficit following aneurysmal subarachnoid hemorrhage.

The cerebral blood vessels, in particular the pia vessels, have a dense non-adrenergic sympathetic nerve supply that originates mainly in the cervical ganglia and accompanies the carotid artery to project into the ipsilateral hemisphere. There is controversy over the physiological significance of sympathetic innervation of the cerebral vasculature and the effect of SGB on it.The intracerebral vessels constrict in response to cervical sympathetic stimulation and dilate when these fibers are interrupted. The release and re-uptake of neurotransmitters, such as bradykinin, which is released during injury, can be prevented by sympathectomy. A recent report has suggested that cervical sympathetic block may be beneficial in patients with subarachnoid haemorrhage and that SGB may have therapeutic value in relieving cerebral vasospasm in certain neurological conditions. Anecdotal mention of SGB in some recent literature encourages the debate on its role as an adjunct to standard therapy for cerebral vasospasm, albeit, with a strong need for further evaluation

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA: I, II
  • Head trauma
  • Hemodynamically stable patient
  • Mechanically ventilated or not
  • SAH diagnosed by CT brain

Exclusion criteria

  • relative refusal.
  • allergy to local anesthetic.
  • Any coagulation disorder.
  • Any vascular disease.
  • Penetrating head trauma.
  • Poly traumatized patient.

Treatment and study plan

stellate ganglion block by transcranial doppler

Procedure

stellate ganglion block is a block of sympathetic ganglion

Nimodipine

Drug

Nimodipine 60mg every 4h

Primary outcomes

  1. cerebral blood flow velocity

    Time frame: From 10 minutes to 24 hour after block

    Asses changes of cerebral blood flow velocity by Trans cranial Doppler

Secondary outcomes

  1. clinical status

    Time frame: Over 10 days

    Asses changes in clinical status by galsco coma scale

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Stellate Ganglion Block as Adjuvant Therapy to ca Channel Blocker in Prevention of Cerebrovascular Spasm in Traumatic Subarachnoid Hemorrhage

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 24, 2019
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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