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

NCT ID: NCT05130333

Last Updated: 2021-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2023-02-22

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.

Conditions

Intraoperative Monitoring; Depth of Anesthesia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-cardiac surgery patients under general anesthesia

\> 18y/o patients undergoing noncardiac surgery with BIS monitoring under general anesthesia.

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Yan, Doctor

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Fengjiang Zhang, Doctor

Role: CONTACT

zrzfj@zju.edu.cn

+86 13858007629

Facility Contacts

Min Yan, Doctor

Role: primary

zryanmin@zju.edu.cn

Other Identifiers

2021-0582

Identifier Type: -

Identifier Source: org_study_id