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

This study has been terminated.
(Recruiting was not as anticipated.)
Sponsor:
Information provided by (Responsible Party):
Ludmyla Kachko, Schneider Children's Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01216501
First received: October 6, 2010
Last updated: November 19, 2014
Last verified: November 2014
  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:

Primary Outcome Measures:
  • No statistic information due to the small amount of participants. [ Time Frame: No statistic information due to the small amount of participants. ] [ Designated as safety issue: No ]
    No statistic information due to the small amount of participants.


Enrollment: 32
Study Start Date: November 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (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

Locations
Israel
Schneider Medical Center of Israel
Petah-Tikva, Israel
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: Ludmyla Kachko, MD, Anesthetic physician, Schneider Children's Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01216501     History of Changes
Other Study ID Numbers: LK-02/2010
Study First Received: October 6, 2010
Last Updated: November 19, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Sevoflurane
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on June 30, 2015