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临床试验/NCT03658057
NCT03658057已完成不适用

Recording Sympathetic Nerve Activity From the Skin During Surgery Under General Anesthesia : a Pilot Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年8月31日最近更新:
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
20
试验地点
1
主要终点
The skin sympathetic nerve activity presented as uV obtained via skin leads.

研究概览

简要总结

Sympathetic nerve activity can be measured transcutaneously in awake patients by computer-based filtering of raw signal obtained via skin leads attached on the chest. Electrocardiogram can be removed by applying a high-pass filter setting of 150 Hz. Electromyogram can be filtered by applying a high-pass filter setting of 500 Hz or a band-pass filter setting of 500-1000 Hz.

However, it is not known whether the skin sympathetic nerve activity (SKNA) can be measured in anesthetized and/or paralyzed patients. Therefore, we planned this pilot study to observe whether the SKNA can be obtained in these patients. If the SKNA ca be observed, it will be presented in milivolt (uV).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • patients scheduled to undergo resection of breast cancer under general anesthesia after insertion of laryngeal mask airway

排除标准

  • Autonomic nervous system disease
  • Medication acting on the autonomic nervous system
  • Refuse to participate

研究组 & 干预措施

ROC

Active Comparator

Neuromuscular blockade is performed in the ROC group by administering rocuronium 0.4~0.8mg/kg before the insertion of laryngeal airway.

干预措施: Rocuronium (Drug)

结局指标

主要结局

The skin sympathetic nerve activity presented as uV obtained via skin leads.

时间窗: During surgery/anesthesia

A few studies reported that skin sympathetic nerve activity (SKNA) signal could be potentially observed by applying a high-pass filter of 500 Hz or a band-pass filter of 500\~1000 Hz to electric signal from skin leads attached on the skin of the chest in awake volunteers. However, it is not known if it would be also possible to observe the SKNA signal in anesthetized patients. Also, there is no established method for quantitative or qualitative assessment of the SKNA signal.

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

Yunseok Jeon

Professor

Seoul National University Hospital

研究点 (1)

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