NCT01043419已完成1 期
Sympathetic Neural Outflow During Xenon Anesthesia in Humans
Air Liquide Santé International1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2010年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake
研究概览
简要总结
The purpose of this study is to test the hypothesis that sympathetic neural outflow to muscles as well as a sympathetic baroreflexes are not altered during xenon anesthesia in Healthy Volunteers.
详细描述
Objectives for this study :
- Main Objective : Influence of Xenon anesthesia on Sympathetic Nervous Activity
- Secondary Objectives : Security under LENOXe™ (xénon 100 % v/v) anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy volunteers > 18 years and < 65 years of age
- •ASA physical status I
- •Legal competence
- •for whom the consent form has been signed
排除标准
- •Healthy volunteers < 18 years and > 65 years of age
- •Pregnancy, lactation period or missing secure anticonvulsive therapy
- •Missing legal competence
- •Participation in other clinical trials
- •Contraindications as mentioned on §4.3 of the SPCs of LENOXe™ (xénon 100 % v/v)
- •Any medication especially of Sildenafil (Viagra®) or other potency remedy
- •Existing relationship of dependency to the sponsor or the investigator
研究组 & 干预措施
LENOXe™ (xénon 100 % v/v)
Experimental
Influence of LENOXe™ (xénon 100 % v/v) anesthesia on Sympathetic Nervous Activity and Security under LENOXe™ (xénon 100 % v/v) anesthesia
干预措施: xenon (Drug)
结局指标
主要结局
Muscle Sympathetic Activity (MSA)and Baroreflex reagibility under Xenon Anesthesia in comparison to awake
时间窗: 30 minutes
次要结局
- Arterial blood pressure, Heart frequency, Arterial O2 and CO2 Saturation,Skin conductance,Concentration of plasma catecholamines, Angiotensin & Renin under Xenon Anesthesia in comparison to awake(In continuous during 30 minutes)
研究者
研究点 (1)
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„Sympathetic neural outflow during Xenon anesthesia in humansWe would like to frame the thesis, that a general, inhalative Xenon anesthesia (1 MAC) does not effect the sympathetic outflow and the sympathetic baroreflex reagibility under spontaneous breathing. Therefore we intend to monitor and document ECG (heartrate), pulsoximetry (SpO2), transcutanous pO2 and PCO2, invasive blood pressure (A. rad.), microneurographic results (MSA –bursts/minute or burst/100 heart beats) and baroreflexreagibility (MSA/DAP evoked by SNP or Phenylepinephrine).EUCTR2009-012449-48-DEAir Liquide Santé International8
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