Sevoflurane and Isoflurane for RF or Cryo Ablation in Children. (--)
Recruitment status was Not yet recruiting
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Purpose
In children, radiofrequency catheter ablation (RFCA) or cryoablation are highly effective treatments for supraventricular tachycardia treatment. General anesthesia is often required to ensure comfort during the prolonged procedure and to assure immobility in order to facilitate accurate mapping and subsequent ablation of the accessory pathway and/or arrhythmogenic focus. Successful anesthetic management of this patient population requires adequate suppression of sympathetic responses during the procedure while electrophysiological parameters remain unaltered for mapping purposes and subsequent ablation. Although Sevoflurane (SEVO) and Isoflurane (ISO) are two commonly used and evaluated volatile anesthetic agents for ablation procedures, comparison of those agents has not been performed previously not in adults, not in children.
Hypothesis Time required for basic EP intervals, successful induction of SVT and successful RFCA or cryoablation in children will not be different between patients undergoing Sevoflurane or Isoflurane-based anesthesia.
| Condition |
|---|
|
Supraventricular Tachycardia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Comparison of Electrophysiological Effects of Sevoflurane and Isoflurane-based Anesthesia in Children Undergoing RF Ablation or Cryoablation for SVT Treatment. A Randomized Double Blind Study. |
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 8 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients who are scheduled for elective radiofrequency ablation or cryoablation to interrupt abnormal foci and/or accessory pathways at Schneider Children's Medical Center of Israel (SCMCI).
Inclusion Criteria:
healthy patients aged 4 to 18 years, with an ASA physical status I or II, who are scheduled for elective radiofrequency ablation or cryoablation to treat SVT.
Exclusion Criteria:
patients with accompanying cardiac defects or other diseases, suspected Malignant Hyperthermia, contraindication to volatile anesthetics use and patients/ parental refusal.
Contacts and Locations| Contact: Ludmyla Kachko, MD | +972-50-7917176 | kachko_l@hotmail.com |
| Contact: Na'ama Tirosh, MA | +972-54-6266171 | tiroshnn@gmail.com |
| Israel | |
| Schneider Medical Center of Israel | Not yet recruiting |
| Petah-Tikva, Israel | |
| Contact: Na'ama Tirosh, MA +972-54-6266171 tiroshnn@gmail.com | |
| Principal Investigator: Ludmyla Kachko, MD | |
| Sub-Investigator: Einat Birk, MD | |
| Sub-Investigator: Rami Fogelman, MD | |
| Sub-Investigator: Yacov Katz, MD | |
| Sub-Investigator: Michael Levenzon, MD | |
| Sub-Investigator: Konstantin Nekrasov, MD | |
| Principal Investigator: | Ludmyla Kachko, MD | Schneider Medical Cebter of Israel |
More Information
No publications provided
| Responsible Party: | Kachko Ludmyla, Schneider Medical center |
| ClinicalTrials.gov Identifier: | NCT01216501 History of Changes |
| Other Study ID Numbers: | LK-02/2010 |
| Study First Received: | October 6, 2010 |
| Last Updated: | October 6, 2010 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Supraventricular Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Isoflurane Sevoflurane Anesthetics, Inhalation |
Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013