Subarachnoid HemorrhagePhase 2NCT04100824
Stellate Ganglion Block as Adjuvant Therapy to ca Channel Blocker
A Phase 2 study testing stellate ganglion block by transcranial doppler and Nimodipine in people with Subarachnoid Hemorrhage, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- stellate ganglion block by transcranial doppler and Nimodipine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jan 2020to 12 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA: I, II
- Head trauma
- Hemodynamically stable patient
- Mechanically ventilated or not
- SAH diagnosed by CT brain
Who cannot join
- relative refusal.
- allergy to local anesthetic.
- Any coagulation disorder.
- Any vascular disease.
- Penetrating head trauma.
- Poly traumatized patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stellate Ganglion Block as Adjuvant Therapy to ca Channel Blocker in Prevention of Cerebrovascular Spasm in Traumatic Subarachnoid Hemorrhage
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
Read the 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
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- stellate ganglion block by transcranial doppler, Nimodipine
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stellate ganglion block by transcranial dopplerProcedure or surgery
stellate ganglion block is a block of sympathetic ganglion
NimodipineDrug
Nimodipine 60mg every 4h
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 0.5% | Experimental | patient will take stellate ganglion block 10 ml bupivacaine 0.5% and nimodipine Receives: Procedure: stellate ganglion block by transcranial doppler; Drug: Nimodipine |
| Nimodipine | Active comparator | patient will take nimodipine 60 mg every 4 h. Receives: Drug: Nimodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral blood flow velocity
Asses changes of cerebral blood flow velocity by Trans cranial Doppler
Measured: From 10 minutes to 24 hour after block
Secondary outcomes (1)
clinical status
Asses changes in clinical status by galsco coma scale
Measured: Over 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start11 Jan 2020
- Primary completion11 Dec 2022
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, m mostfa youssef mekky, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100824
- Sponsor's protocol ID
- stellate ganglion block
- Status last verified
- Jun 2023
- First submitted
- 19 Sep 2019
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Block as Adjuvant Therapy to ca Channel Blocker in Prevention of Cerebrovascular Spasm in Traumatic Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT04100824
- Acronym / sponsor ID
- stellate ganglion block
- Conditions
- Subarachnoid Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 11 Dec 2022 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 0.5% | Experimental | Procedure: stellate ganglion block by transcranial doppler, Drug: Nimodipinepatient will take stellate ganglion block 10 ml bupivacaine 0.5% and nimodipine |
| Nimodipine | Active comparator | Drug: Nimodipinepatient will take nimodipine 60 mg every 4 h. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- ASA: I, II
- Head trauma
- Hemodynamically stable patient
- Mechanically ventilated or not
- SAH diagnosed by CT brain
Key exclusion criteria (6 listed)
- relative refusal.
- allergy to local anesthetic.
- Any coagulation disorder.
- Any vascular disease.
- Penetrating head trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stellate ganglion block by transcranial dopplerstellate ganglion block is a block of sympathetic ganglion | Procedure or surgery | Bupivacaine 0.5% |
| NimodipineNimodipine 60mg every 4h | Drug | Bupivacaine 0.5%, Nimodipine |
Primary outcome
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
1 secondary outcome
clinical status
Time frame: Over 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stellate ganglion block by transcranial doppler and Nimodipine in people with Subarachnoid Hemorrhage, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral blood flow velocity (time frame: From 10 minutes to 24 hour after block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.