Traumatic Brain InjuryEarly Phase 1NCT05182619
Stellate Block Versus Nimodipine Infusion for Traumatic Brain Injury
A Early Phase 1 study testing ultrasound-guided stellate ganglion block in people with Traumatic Brain Injury, run by Sohag University.
Trial summary
the study is designed to perform an intervention for enhancement of cerebral blood flow in patients with traumatic brain injury showing vasospasm through transcranial doppler Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- ultrasound-guided stellate ganglion block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Apr 2023
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients more than 18 ys old with isolated head trauma and traumatic brain injury
Who cannot join
- • Hemodynamic instability (mean ABP less than 70 mmHg)
- History of severe systemic disease including cardiopulmonary failure or hepatorenal failure
- Allergy to local anesthetics
- Coagulation disorders
- Abnormal neck structures disturbing normal anatomy as neck tumors
About this study
Official title: Ultrasound-guided Stellate Ganglion Block Versus Nimodipine Infusion for Enhancement of Cerebral Blood Flow in Traumatic Brain Injury
the study is designed to perform an intervention for enhancement of cerebral blood flow in patients with traumatic brain injury showing vasospasm through transcranial doppler
- Conditions
- Traumatic Brain Injury
- Being tested
- ultrasound-guided stellate ganglion block
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided stellate ganglion blockProcedure or surgery
under aseptic conditions, using the ultrasound guidance, bilateral stellate ganglion block will be done using bupivacaine and betamethasone mixture, 8 ml volume will be given for each side
| Study group | Role | What they receive |
|---|---|---|
| ultrasoung guided stellate block | Active comparator | stellate ganglion will have ultrasound-guided block via bupivacaine for sympathectomy and enhancement of cerebral blood flow Receives: Procedure: ultrasound-guided stellate ganglion block |
| nimodipine infusion | Active comparator | intravenous nimodipine will be given for enhancement of cerebral blood flow Receives: Procedure: ultrasound-guided stellate ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
enhancement of cerebral blood flow
increased blood flow through middle cerebral artery and basilar artery measured by transcranial doppler ultraound
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mohamed Abdelaal, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182619
- Sponsor's protocol ID
- soh-Med-21-12-19
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Stellate Ganglion Block Versus Nimodipine Infusion for Enhancement of Cerebral Blood Flow in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05182619
- Acronym / sponsor ID
- soh-Med-21-12-19
- Conditions
- Traumatic Brain Injury
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 10 Jan 2022 (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.
the study is designed to perform an intervention for enhancement of cerebral blood flow in patients with traumatic brain injury showing vasospasm through transcranial doppler
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasoung guided stellate block | Active comparator | Procedure: ultrasound-guided stellate ganglion blockstellate ganglion will have ultrasound-guided block via bupivacaine for sympathectomy and enhancement of cerebral blood flow |
| nimodipine infusion | Active comparator | Procedure: ultrasound-guided stellate ganglion blockintravenous nimodipine will be given for enhancement of cerebral blood flow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients more than 18 ys old with isolated head trauma and traumatic brain injury
Key exclusion criteria (5 listed)
- • Hemodynamic instability (mean ABP less than 70 mmHg)
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 |
|---|---|---|
| ultrasound-guided stellate ganglion blockunder aseptic conditions, using the ultrasound guidance, bilateral stellate ganglion block will be done using bupivacaine and betamethasone mixture, 8 ml volume will be given for each side | Procedure or surgery | nimodipine infusion, ultrasoung guided stellate block |
Primary outcome
enhancement of cerebral blood flow
Time frame: one week
increased blood flow through middle cerebral artery and basilar artery measured by transcranial doppler ultraound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ultrasound-guided stellate ganglion block in people with Traumatic Brain Injury, run by Sohag University.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
enhancement of cerebral blood flow (time frame: one week). 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 10 Jan 2022.