Stellatar Ganglione Blockage for Ventricular Arrhytmias

January 25, 2023 updated by: Cağatay Küçükbingöz, Adana City Training and Research Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yuregir
      • Adana, Yuregir, Turkey, 01170
        • AdanaCityTRH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ventricular tachycardia (VT)
  • Ventricular fibrillation (VF)
  • Electrical storm (ES)

Exclusion Criteria:

  • Resistant ventricular arrhythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: stellat gagnliyon blockadge
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.
stellate blockade effect on Ventricular arrytmia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
ICD shock requirement
Time Frame: 6 months
Determination of 6-month number of ICD shock (Joule) requirement after stellate ganglion blockade.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ACTUAL)

March 24, 2022

Study Completion (ACTUAL)

March 24, 2022

Study Registration Dates

First Submitted

December 17, 2022

First Submitted That Met QC Criteria

January 25, 2023

First Posted (ACTUAL)

February 3, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 125-85

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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