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临床试验/NCT05130333
NCT05130333Unknown不适用

The Clinical Research of Needle Electrodes Used in Bispectral Index to Monitor the Depth of Anesthesia

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年11月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Correlation coefficient

研究概览

简要总结

In this study, the EEG information of patients was collected by different BIS electrodes, in order to compare the quality of EEG signals obtained by subdermal needle electrodes and the original BIS sensors, and try to use primitive EEG signals to develop a new calculation of needle electrode to monitor the depth of anesthesia.

详细描述

After the patient enters the room, non-invasive BP, HR, end-tidal CO2, SPO2 and other routine monitoring are performed, and the corresponding BIS electrodes are worn to the patient. The anesthesiologist decides whether to perform invasive hemodynamic monitoring, such as invasive arterial blood pressure monitoring, central venous pressure monitoring, etc., depending on the patient's condition and surgical requirements. The induction and maintenance of anesthesia is the routine scheme in the Second Affiliated Hospital of Zhejiang University , and the medication and dose are based on the judgment of the main anesthesiologist . After induction, endotracheal intubation was performed and mechanical ventilation was given. After anesthesia induction, install subcutaneous needle electrode to the patient. BIS values were collected using two BIS monitoring systems, one using the original BIS sensor and the other connected to the needle electrodes.During the operation, the anesthesiologist adjusted the depth of anesthesia according to the original BIS value, and propofol was used to improve the depth of sedation if the BIS value was greater than 60. In this study, surface acoustic wave electronic nose was used to monitor the exhaled propofol concentration of patients undergoing general anesthesia.The BIS value, hemodynamic information, exhaled propofol concentration and plasma propofol concentration were recorded.

研究设计

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

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

  • Over 18 years old
  • Patients undergoing General Anesthesia surgery requiring BIS Monitoring
  • Obtained informed consent

排除标准

  • Patients who have mental disorders and unable to answer
  • Patients who have taken anti-epileptic drugs and psychotropic drugs for a long time
  • Patients who are pregnant
  • Patients who refuse to participate in this trial
  • Patients considered by the investigator to be unsuitable for inclusion in the trial

结局指标

主要结局

Correlation coefficient

时间窗: Through study completion, an average of 2 year

The correlation coefficient between the BIS value measured by the subdermal needle electrodes and the BIS value measured by the original BIS sensors

次要结局

  • Correlation between BIS values and propofol concentration(Through study completion, an average of 2 year)
  • Correlation between BIS values and blood pressure and heart rate(Through study completion, an average of 2 year)
  • Correlation between BIS values and OAA/S score(Through study completion, an average of 2 year)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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