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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intraoperative Monitoring; Depth of Anesthesia
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Fengjiang Zhang, Doctor; Phone Number: +86 13858007629; Email: zrzfj@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

General anesthesia patients undergoing non-cardiac surgery

Description

Inclusion Criteria:

• ASAⅠ~Ⅲ
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-cardiac surgery patients under general anesthesia; > 18y/o patients undergoing noncardiac surgery with BIS monitoring under general anesthesia.	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 29, 2021
• Primary Completion (Anticipated): October 22, 2022
• Study Completion (Anticipated): February 22, 2023

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: sedation; BIS; Needle electrodes
• Other Study ID Numbers: 2021-0582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No