NCT Number: NCT07211347
There is no randomized clinical study in the literature that evaluated the efficacy and safety of the stellate ganglion infiltration procedure in patients with electrical storm. So far, case reports and retrospective studies suggest that such a strategy should be considered in cases refractory to initial therapy. In this scenario, the European and American guidelines for the treatment of ventricular arrhythmias recommend autonomic modulation in this setting, but only with a level of recommendation IIb (1,2). This project aims to evaluate the effect of stellate ganglion infiltration in patients with electric storm refractory to initial clinical measures. It is a randomized clinical trial where patients will receive treatment with a lidocaine and bupivacaine anesthetic solution or no intervention. The effect of the intervention will be considered positive when there is a reduction of arrhythmic events of at least 50% in the 12 hours immediately after.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
São Paulo, 05409011, Brazil
Location status: Recruiting
Alberto P Ferraz, MD
CONTACT
Alberto P Ferraz, MD
SUB_INVESTIGATOR
Maurício I Scanavacca, MD, PhD
PRINCIPAL_INVESTIGATOR
Rodrigo M Kulchetscki, MD
SUB_INVESTIGATOR
CONTACT
The study aims to evaluate the reduction of arrhythmic events following stellate ganglion blockade in patients with electrical storm refractory to initial clinical measures.
Hypothesis Stellate ganglion infiltration is an effective neuromodulation strategy for controlling arrhythmic events in patients with electrical storm awaiting definitive therapy.
Methodology This is a single-center randomized study investigating the efficacy of stellate ganglion blockade in patients with electrical storm refractory to initial clinical measures.
Participant Selection and Sample Size Participants will include patients admitted to the Emergency Unit or any Intensive Care Unit with a diagnosis of refractory electrical storm. Based on the STAR study, which reported a median of 6 arrhythmic events before SGB (IQR: 3 to 15.8), and aiming for at least a 50% reduction in arrhythmias in the active group post-procedure (with no expected change in the placebo group), a sample size of 32 patients per group was calculated (alpha = 0.05, power = 80%, two-tailed test).
Definitions Electrical storm (ES) is defined as three or more episodes of ventricular arrhythmias (including appropriate ICD therapies), separated by at least 5 minutes, within 24 hours. Refractory ES is defined as recurrent arrhythmias despite antiarrhythmic drug administration. Patients requiring discontinuation of antiarrhythmics due to adverse events will also be eligible for SGB. An arrhythmic event is defined as an episode of sustained VT or VF (>30 seconds or unstable), treated or not with antitachycardia pacing (ATP), electrical therapy, ICD shock, or external defibrillation. Pre-specified complications include: simple hematoma, hematoma requiring intervention, symptoms due to anesthetic absorption, brachial plexus injury, simple vascular injury, and vascular injury requiring intervention.
Randomization Randomization will be performed by a medical professional not involved in the infiltration procedure and blinded to data analysis, using the "Randomizer for Clinical Trial" software.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
There is no randomized clinical study in the literature that evaluated the efficacy and safety of the stellate ganglion infiltration procedure in patients with electrical storm.
Time frame: 12 hours immediately after the blockade compared to the 12 hours immediately before
A ≥50% reduction in arrhythmic events (VT/VF)
Time frame: 12 hours immediately after stellate ganglion block (SGB) compared to the 12 hours immediately before
Reduction in the number of ATPs/ICD shocks
Time frame: 72 hours after the blockade
urgent ablation and other invasive therapies (e.g., intra-aortic balloon pump placement or intubation for deep sedation)
Contact information is provided by the study sponsor or research team.
University of Sao Paulo General Hospital
Other
Percutaneous Blockade Protocol of the Stellate Ganglion in Patients With Refractory Electrical Storm
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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