Sevoflurane and Isoflurane for RF or Cryo Ablation in Children.

NCT01216501 | Terminated

• 1 other identifier: LK-02/2010
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Supraventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• No statistic information due to the small amount of participants.

  No statistic information due to the small amount of participants.

  No statistic information due to the small amount of participants.

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• patients with accompanying cardiac defects or other diseases, suspected Malignant Hyperthermia, contraindication to volatile anesthetics use and patients/ parental refusal.

Sponsors & Collaborators

• Schneider Children's Medical Center, Israel: lead

Study Sites (1)

Schneider Medical Center of Israel

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ludmyla Kachko, MD

  Schneider Medical Cebter of Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthetic physician

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: November 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

IL (1)