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临床试验/NCT02419547
NCT02419547已完成不适用

Inducibility and Stability of Ventricular Tachycardia in Patients With Structural Heart Disease Undergoing VT Ablation Under General Anesthesia (Pilot Study)

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia.

研究概览

简要总结

This research study is being done to see whether general anesthesia (GA) affects our ability to start ventricular tachycardia (VT) during an VT ablation procedure.

Data collected during this research study will help electrophysiologists and anesthesiologists to make the best decisions about the best anesthetic conditions to use to perform VT ablations.

This research study is a "pilot" study. Pilot studies are done on a small group of subjects to learn if a larger study would be useful.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with VT and have an implanted ICD who are scheduled for VT catheter ablation.
  • Patients 18 years of age or older

排除标准

  • Patients with difficult airway management or patients with contra/ relative contra indication for general anesthesia or known allergies to any of the proposed anesthetic agents
  • Women who are pregnant

研究组 & 干预措施

Anesthesia Induction

Other

Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).

干预措施: Versed (Drug)

Anesthesia Induction

Other

Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).

干预措施: Fentanyl (Drug)

Anesthesia Induction

Other

Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).

干预措施: Propofol (Drug)

Anesthesia Induction

Other

Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia.

时间窗: While under General Anesthesia, an average of 6 hours

Patients before induction of GA undergo noninvasive programmed stimulation (NIPS) using the patient's ICD. Subjects receive minimal versed/fentanyl during the NIPS. The anesthesiologist will decide whether to use propofol prior to the second induction, depending on the patient's cardiac function and hemodynamic status. After induction of GA with IV propofol, programmed stimulation will be performed from the RV catheter. Mapping under volatile agent will commence any time after twice the redistribution half-life of either agent has elapsed (propofol 4-16 mins) or have passed. Once the drug is out of the central compartment it is unlikely to affect myocardial electrolytes or ion channels. GA will be maintained with an inhalation agent, sevoflurane. A repeat programmed stimulation test will be performed. Endpoint for programmed stimulation will be induction of sustained monomorphic VT (SMVT).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Shook

Chief, Divison of Cardiac Anesthesia

Brigham and Women's Hospital

研究点 (1)

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