NCT05712122

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

December 17, 2022

Last Update Submit

January 25, 2023

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 months

  • ICD shock requirement

    Determination of 6-month number of ICD shock (Joule) requirement after stellate ganglion blockade.

    6 months

Study Arms (1)

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.

Procedure: stellate block

Interventions

stellate blockPROCEDURE

stellate blockade effect on Ventricular arrytmia

stellat gagnliyon blockadge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Resistant ventricular arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdanaCityTRH

Adana, Yuregir, 01170, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 29270467BACKGROUND

  • 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.

    PMID: 31514529RESULT

  • 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.

    PMID: 32439042RESULT

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 17, 2022

First Posted

February 3, 2023

Study Start

January 1, 2021

Primary Completion

March 24, 2022

Study Completion

March 24, 2022

Last Updated

February 3, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)