Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712122
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2022-12-17
Brief Title:
Stellatar Ganglione Blockage for Ventricular Arrhytmias
Sponsor:
Adana City Training and Research Hospital
Organization:
Adana City Training and Research Hospital
Study Overview
Official Title:
Can Stellar Ganglion Blockage be an Alternative Treatment for Refractory Ventricular Arrhythmias
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Horners syndrome in the left eye
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 Horners 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 VTVF or ICD therapy for VTVF 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 16092022 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 CardiologyAmerican Heart AssociationHeart 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 1415 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 Horners 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
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 CardiologyAmerican Heart AssociationHeart 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 1415 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 Horners 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None