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Stellate Ganglion Block as Adjuvant Therapy to ca Channel Blocker

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ClinicalTrials.gov Identifier: NCT04100824
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
m mostfa youssef mekky, Assiut University

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Procedure: stellate ganglion block by transcranial doppler Drug: Nimodipine Phase 2

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Stellate Ganglion Block as Adjuvant Therapy to ca Channel Blocker in Prevention of Cerebrovascular Spasm in Traumatic Subarachnoid Hemorrhage
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Nimodipine

Arm Intervention/treatment
Experimental: Bupivacaine 0.5%
patient will take stellate ganglion block 10 ml bupivacaine 0.5% and nimodipine
Procedure: stellate ganglion block by transcranial doppler
stellate ganglion block is a block of sympathetic ganglion

Drug: Nimodipine
Nimodipine 60mg every 4h

Active Comparator: Nimodipine
patient will take nimodipine 60 mg every 4 h.
Drug: Nimodipine
Nimodipine 60mg every 4h




Primary Outcome Measures :
  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 Outcome Measures :
  1. clinical status [ Time Frame: From 10 minutes to 24 hour after block ]
    Asses changes in clinical status by galsco coma scale



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. ASA: I, II
  2. Head trauma
  3. Hemodynamically stable patient
  4. Mechanically ventilated or not
  5. SAH diagnosed by CT brain

Exclusion Criteria:

  1. relative refusal.
  2. allergy to local anesthetic.
  3. Any coagulation disorder.
  4. Any vascular disease.
  5. Penetrating head trauma.
  6. Poly traumatized patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100824


Contacts
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Contact: Kawther H Mohamed, prof +201098983009 kawser@aun.edu.eg
Contact: Abdelraheem M Mohamed, Asst.prof.

Locations
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Egypt
ِAssiut University Hospital
Assiut, Egypt, 1111111
Contact: kathwar h mohamed, prof    +201098983009      
Sponsors and Collaborators
Assiut University

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Responsible Party: m mostfa youssef mekky, Lecturer assistant, Assiut University
ClinicalTrials.gov Identifier: NCT04100824    
Other Study ID Numbers: stellate ganglion block
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Nimodipine
Physiological Effects of Drugs
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Vasodilator Agents