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临床试验/NCT01216501
NCT01216501终止不适用

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.

Schneider Children's Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
32
试验地点
1
主要终点
No statistic information due to the small amount of participants.

研究概览

简要总结

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.

详细描述

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.

Patients The study group will include otherwise 200 lthy patients aged 4 to 18 years, with an ASA physical status I or II, 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). Written informed consent will be obtained from the patients (from age 12), parent(s) or legal guardian of all participants. Duration of the study- 2 years.

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

结局指标

主要结局

No statistic information due to the small amount of participants.

时间窗: No statistic information due to the small amount of participants.

No statistic information due to the small amount of participants.

次要结局

未报告次要终点

研究者

发起方
Schneider Children's Medical Center, Israel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ludmyla Kachko

MD, Anesthetic physician

Schneider Children's Medical Center, Israel

研究点 (1)

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