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Clinical Trials/NCT05130333
NCT05130333
Unknown
Not Applicable

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country120 target enrollmentNovember 29, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intraoperative Monitoring
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
120
Locations
1
Primary Endpoint
Correlation coefficient
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 29, 2021
End Date
February 22, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Correlation coefficient

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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