Cardiac ArrhythmiaNCT05712122
Stellatar Ganglione Blockage for Ventricular Arrhytmias
A study testing stellate block in people with Cardiac Arrhythmia, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Ventricular tachycardia (VT) and ventricular fibrillation (VF) are life-threatening conditions that increase in frequency over the years. An electrical storm (ES) is defined as the occurrence of 3 or more continuous ventricular arrhythmia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- stellate block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 24 Mar 2022
- Phase
- Interventional
- 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
- Ventricular tachycardia (VT)
- Ventricular fibrillation (VF)
- Electrical storm (ES)
Who cannot join
- Resistant ventricular arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Stellar Ganglion Blockage be an Alternative Treatment for Refractory Ventricular Arrhythmias?
Ventricular tachycardia (VT) and ventricular fibrillation (VF) are life-threatening conditions that increase in frequency over the years. An electrical storm (ES) is defined as the occurrence of 3 or more continuous ventricular arrhythmia. The sympathetic nervous system has an important role in VA and is the target of treatment. Studies show that stellate ganglion blockade (SGB) can reduce cardiac sympathetic tone and is an alternative bridge therapy in VAs. In our study, the investigators preferred to apply a combination of local anesthetic and steroid in the stellate ganglion blocking method to 10 VA patients who were resistant to medical treatment and had an ICD, and we also planned to examine the 6-month follow-up results of the patients.
In our study, USG-guided left stellate ganglion blockade was applied to 10 VA and ES patients with ICD. The 6-month results of the patients were evaluated retrospectively. For blockage, the solution was prepared by adding 8 mg dexamethasone, 40 mg lidocaine, and 10 mg bupivacaine to 10 mL with physiological saline. The success of the procedure was evaluated with the development of Horner's syndrome in the left eye.
Read the detailed description
In our study, USG-guided left stellate ganglion blockade was applied to 10 VA and ES patients with ICD who were admitted to the Department of Cardiology at Çukurova University between 2020-2021. The 6-month results of the patients were evaluated retrospectively. An electrical storm was defined as 3 episodes of continuous VT/VF or ICD therapy for VT/VF over a 24-hour period. Demographic data and clinical and procedural outcomes of the patients were collected from electronic hospital records. Inpatient telemetry and ICD interrogation logs were reviewed for each patient. Administration of oral and intravenous (IV) anti-arrhythmic drugs (AAD) was recorded for the pre-and post-SGB periods. For our study, approval was taken by the Çukurova University ethics committee on 16.09.2022 with document number 125.
Patient Selection Patients who applied to the Cardiology Department with the diagnosis of VA or ES and did not benefit from antiarrhythmic drug therapy were selected and evaluated by a team of 2 anesthesiologists (cardiothoracic and pain specialists) and 2 cardiologists (1 of whom is an electrophysiology specialist).
All patients received standard treatment modalities based on current American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for the management of VAs (13). These methods included combinations of therapies for reversible causes (medical treatments, metabolic injuries, myocardial ischemia) beta-blockers, IV AADs, noninvasive programmed stimulation for overrate termination, and ICD programming to optimize anti-tachycardia pacing and minimize shocks. The number of shocks in the last 6 months of the patients selected for the application was checked from the ICD device. Patients with persistent VA storms despite at least 1 antiarrhythmic drug therapy with beta-blocker and catheter ablation for VT were included in the study. After the first injection, VT or VF burden and development of shock were assessed by an implantable cardioverter-defibrillator for 48 hours following the procedure.
Stellat Ganglion Block (SGB) Technique In the operating room, the patients undergoing SGB were hospitalized in the supine position with their heads extended. All patients with intravenous access were monitored with ECG, pulse oximetry, and non-invasive blood pressure in accordance with the guidelines of the American Society of Anesthesiology. Left stellate ganglion blockade was planned for all patients and their heads were turned to the right. The left neck and shoulder of the patient were cleaned with chlorhexidine. The linear (13-6 MHz) USG probe was prepared in accordance with the sterilization conditions. Cervical vertebra level was determined in the neck of the patient with the USG probe at the level of the cricoid cartilage. After visualizing the Chassaignac tubercle, longus coli muscle, carotid, esophagus, and thyroid gland of the C6 vertebra, an 80 mm 22-G, USG compatible (B. Braun Stimuplex Ultra 360) needle was inserted into the medial of the Chassaignac tubercle and towards the front of the prevertebral fascia of the longus Colli muscle using the in-plane technique. After the needle site was confirmed, a negative aspiration test was performed and 10 mL of local anesthetic and steroid mixture was injected (14,15). For blockage, the solution was prepared by adding 8 mg dexamethasone, 40 mg lidocaine, and 10 mg bupivacaine to 10 mL with physiological saline. The success of the procedure was evaluated with the development of Horner's syndrome in the left eye. After the procedure, the patients were taken to the Cardiology Intensive Care Unit and ICD follow-up was performed for 24 hours. The medical treatments of the patients who did not develop a new VA within 24 hours were arranged and they were called for follow-up checkups in the 1st and 6th months. During the check-ups, the number of shocks, the presence of newly developed VA, and whether the patient applied to the emergency department due to VA were followed from the ICD records.
- Conditions
- Cardiac Arrhythmia
- Being tested
- stellate block
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stellate blockProcedure or surgery
stellate blockade effect on Ventricular arrytmia
| Study group | Role | What they receive |
|---|---|---|
| stellat gagnliyon blockadge | Experimental | Ultrasound-guided stellate ganglion blockade and for blockage, the solution was prepared by adding 8 mg dexamethasone, 40 mg lidocaine, and 10 mg bupivacaine to 10 mL with physiological saline. Receives: Procedure: stellate block |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventricular arrhythmia numbers
Determination of 6-month number of new ventricular arrhythmias (In ventricular tachycardia, the heart beats faster, usually 100 or more beats a minute) requirement after stellate ganglion blockade.
Measured: 6 months
ICD shock requirement
Determination of 6-month number of ICD shock (Joule) requirement after stellate ganglion blockade.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Jan 2021
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adana City Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cağatay Küçükbingöz, Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712122
- Sponsor's protocol ID
- 125-85
- Status last verified
- Jan 2023
- First submitted
- 17 Dec 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meng L, Tseng CH, Shivkumar K, Ajijola O. Efficacy of Stellate Ganglion Blockade in Managing Electrical Storm: A Systematic Review. JACC Clin Electrophysiol. 2017 Sep;3(9):942-949. doi: 10.1016/j.jacep.2017.06.006.
PubMed 29270467Tian Y, Wittwer ED, Kapa S, McLeod CJ, Xiao P, Noseworthy PA, Mulpuru SK, Deshmukh AJ, Lee HC, Ackerman MJ, Asirvatham SJ, Munger TM, Liu XP, Friedman PA, Cha YM. Effective Use of Percutaneous Stellate Ganglion Blockade in Patients With Electrical Storm. Circ Arrhythm Electrophysiol. 2019 Sep;12(9):e007118. doi: 10.1161/CIRCEP.118.007118. Epub 2019 Sep 13.
PubMed 31514529Fudim M, Qadri YJ, Waldron NH, Boortz-Marx RL, Ganesh A, Patel CB, Podgoreanu MV, Sun AY, Milano CA, Tong BC, Harpole DH Jr, Mathew JP, Piccini JP. Stellate Ganglion Blockade for the Treatment of Refractory Ventricular Arrhythmias. JACC Clin Electrophysiol. 2020 May;6(5):562-571. doi: 10.1016/j.jacep.2019.12.017. Epub 2020 Feb 26.
PubMed 32439042
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Stellar Ganglion Blockage be an Alternative Treatment for Refractory Ventricular Arrhythmias?
- ClinicalTrials.gov ID
- NCT05712122
- Acronym / sponsor ID
- 125-85
- Conditions
- Cardiac Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Adana City Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 3 Feb 2023 (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.
Ventricular tachycardia (VT) and ventricular fibrillation (VF) are life-threatening conditions that increase in frequency over the years. An electrical storm (ES) is defined as the occurrence of 3 or more continuous ventricular arrhythmia. The sympathetic nervous system has an important role in VA and is the target of treatment. Studies show that stellate ganglion blockade (SGB) can reduce cardiac sympathetic tone and is an alternative bridge therapy in VAs. In our study, the investigators preferred to apply a combination of local anesthetic and steroid in the stellate ganglion blocking method to 10 VA patients who were resistant to medical treatment and had an ICD, and we also planned to examine the 6-month follow-up results of the patients.
In our study, USG-guided left stellate ganglion blockade was applied to 10 VA and ES patients with ICD. The 6-month results of the patients were evaluated retrospectively. For blockage, the solution was prepared by adding 8 mg dexamethasone, 40 mg lidocaine, and 10 mg bupivacaine to 10 mL with physiological saline. The success of the procedure was evaluated with the development of Horner's syndrome in the left eye.
Detailed description
In our study, USG-guided left stellate ganglion blockade was applied to 10 VA and ES patients with ICD who were admitted to the Department of Cardiology at Çukurova University between 2020-2021. The 6-month results of the patients were evaluated retrospectively. An electrical storm was defined as 3 episodes of continuous VT/VF or ICD therapy for VT/VF over a 24-hour period. Demographic data and clinical and procedural outcomes of the patients were collected from electronic hospital records. Inpatient telemetry and ICD interrogation logs were reviewed for each patient. Administration of oral and intravenous (IV) anti-arrhythmic drugs (AAD) was recorded for the pre-and post-SGB periods. For our study, approval was taken by the Çukurova University ethics committee on 16.09.2022 with document number 125.
Patient Selection Patients who applied to the Cardiology Department with the diagnosis of VA or ES and did not benefit from antiarrhythmic drug therapy were selected and evaluated by a team of 2 anesthesiologists (cardiothoracic and pain specialists) and 2 cardiologists (1 of whom is an electrophysiology specialist).
All patients received standard treatment modalities based on current American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for the management of VAs (13). These methods included combinations of therapies for reversible causes (medical treatments, metabolic injuries, myocardial ischemia) beta-blockers, IV AADs, noninvasive programmed stimulation for overrate termination, and ICD programming to optimize anti-tachycardia pacing and minimize shocks. The number of shocks in the last 6 months of the patients selected for the application was checked from the ICD device. Patients with persistent VA storms despite at least 1 antiarrhythmic drug therapy with beta-blocker and catheter ablation for VT were included in the study. After the first injection, VT or VF burden and development of shock were assessed by an implantable cardioverter-defibrillator for 48 hours following the procedure.
Stellat Ganglion Block (SGB) Technique In the operating room, the patients undergoing SGB were hospitalized in the supine position with their heads extended. All patients with intravenous access were monitored with ECG, pulse oximetry, and non-invasive blood pressure in accordance with the guidelines of the American Society of Anesthesiology. Left stellate ganglion blockade was planned for all patients and their heads were turned to the right. The left neck and shoulder of the patient were cleaned with chlorhexidine. The linear (13-6 MHz) USG probe was prepared in accordance with the sterilization conditions. Cervical vertebra level was determined in the neck of the patient with the USG probe at the level of the cricoid cartilage. After visualizing the Chassaignac tubercle, longus coli muscle, carotid, esophagus, and thyroid gland of the C6 vertebra, an 80 mm 22-G, USG compatible (B. Braun Stimuplex Ultra 360) needle was inserted into the medial of the Chassaignac tubercle and towards the front of the prevertebral fascia of the longus Colli muscle using the in-plane technique. After the needle site was confirmed, a negative aspiration test was performed and 10 mL of local anesthetic and steroid mixture was injected (14,15). For blockage, the solution was prepared by adding 8 mg dexamethasone, 40 mg lidocaine, and 10 mg bupivacaine to 10 mL with physiological saline. The success of the procedure was evaluated with the development of Horner's syndrome in the left eye. After the procedure, the patients were taken to the Cardiology Intensive Care Unit and ICD follow-up was performed for 24 hours. The medical treatments of the patients who did not develop a new VA within 24 hours were arranged and they were called for follow-up checkups in the 1st and 6th months. During the check-ups, the number of shocks, the presence of newly developed VA, and whether the patient applied to the emergency department due to VA were followed from the ICD records.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stellat gagnliyon blockadge | Experimental | Procedure: stellate blockUltrasound-guided stellate ganglion blockade and for blockage, the solution was prepared by adding 8 mg dexamethasone, 40 mg lidocaine, and 10 mg bupivacaine to 10 mL with physiological saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ventricular tachycardia (VT)
- Ventricular fibrillation (VF)
- Electrical storm (ES)
Key exclusion criteria (1 listed)
- Resistant ventricular arrhythmia
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 blockstellate blockade effect on Ventricular arrytmia | Procedure or surgery | stellat gagnliyon blockadge |
Primary outcome
ventricular arrhythmia numbers
Time frame: 6 months
Determination of 6-month number of new ventricular arrhythmias (In ventricular tachycardia, the heart beats faster, usually 100 or more beats a minute) requirement after stellate ganglion blockade.
ICD shock requirement
Time frame: 6 months
Determination of 6-month number of ICD shock (Joule) requirement after stellate ganglion blockade.
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 3 Feb 2023.
- Background: PubMed 29270467Meng L, Tseng CH, Shivkumar K, Ajijola O. Efficacy of Stellate Ganglion Blockade in Managing Electrical Storm: A Systematic Review. JACC Clin Electrophysiol. 2017 Sep;3(9):942-949. doi: 10.1016/j.jacep.2017.06.006.
- Results publication: PubMed 31514529Tian Y, Wittwer ED, Kapa S, McLeod CJ, Xiao P, Noseworthy PA, Mulpuru SK, Deshmukh AJ, Lee HC, Ackerman MJ, Asirvatham SJ, Munger TM, Liu XP, Friedman PA, Cha YM. Effective Use of Percutaneous Stellate Ganglion Blockade in Patients With Electrical Storm. Circ Arrhythm Electrophysiol. 2019 Sep;12(9):e007118. doi: 10.1161/CIRCEP.118.007118. Epub 2019 Sep 13.
- Results publication: PubMed 32439042Fudim M, Qadri YJ, Waldron NH, Boortz-Marx RL, Ganesh A, Patel CB, Podgoreanu MV, Sun AY, Milano CA, Tong BC, Harpole DH Jr, Mathew JP, Piccini JP. Stellate Ganglion Blockade for the Treatment of Refractory Ventricular Arrhythmias. JACC Clin Electrophysiol. 2020 May;6(5):562-571. doi: 10.1016/j.jacep.2019.12.017. Epub 2020 Feb 26.
- Individual participant dataSharing planned: No
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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 study testing stellate block in people with Cardiac Arrhythmia, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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 3 Feb 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 Turkey (Türkiye). 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.
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?
ventricular arrhythmia numbers (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05712122, which also lists 3 linked publications.
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 3 Feb 2023.