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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • AdanaCityTRH

    Adana, Yuregir, 01170

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05712122
Study groupRoleWhat they receive
stellat gagnliyon blockadgeExperimentalUltrasound-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.

  1. 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

  2. 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.

  1. First posted3 Feb 2023
  2. Study start1 Jan 2021
  3. Primary completion24 Mar 2022
  4. Study completion24 Mar 2022

Resources

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)
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 29270467
  • Tian 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 31514529
  • Fudim 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

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.

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