Sevoflurane and Isoflurane for RF or Cryo Ablation in Children. (--)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Schneider Children's Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Schneider Children's Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01216501
First received: October 6, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  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.

Resource links provided by NLM:


Further study details as provided by Schneider Children's Medical Center, Israel:

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
Study Population

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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216501

Contacts
Contact: Ludmyla Kachko, MD +972-50-7917176 kachko_l@hotmail.com
Contact: Na'ama Tirosh, MA +972-54-6266171 tiroshnn@gmail.com

Locations
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         
Sponsors and Collaborators
Schneider Children's Medical Center, Israel
Investigators
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
Sevoflurane
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014