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

Intraoperative Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05130333
• Other study ID #: 2021-0582
• Status: Not yet recruiting
• Start date: November 29, 2021
• Est. completion date: February 22, 2023

Study information

• Verified date: October 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Fengjiang Zhang, Doctor
• Phone: +86 13858007629
• Email: zrzfj[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 22, 2023
• Est. primary completion date: October 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA?~?
• 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

Related Conditions & MeSH terms

• Depth of Anesthesia
• Intraoperative Monitoring

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation coefficient	The correlation coefficient between the BIS value measured by the subdermal needle electrodes and the BIS value measured by the original BIS sensors	Through study completion, an average of 2 year
Secondary	Correlation between BIS values and OAA/S score	Comparison of the correlation between BIS values measured by two kinds of electrodes and OAA/S	Through study completion, an average of 2 year
Secondary	Correlation between BIS values and propofol concentration	Correlation between BIS values measured by two kinds of electrodes and propofol concentration in blood From Exhaled Gas	Through study completion, an average of 2 year
Secondary	Correlation between BIS values and blood pressure and heart rate	Correlation between BIS values measured by two kinds of electrodes and blood pressure and heart rate	Through study completion, an average of 2 year