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

NCT ID: NCT05130333

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-29

Study Completion Date

2023-02-22

Brief Summary

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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

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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

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Intraoperative Monitoring Depth of Anesthesia

Keywords

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sedation Needle electrodes BIS

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Yan, Doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Fengjiang Zhang, Doctor

Role: CONTACT

Phone: +86 13858007629

Email: [email protected]

Facility Contacts

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Min Yan, Doctor

Role: primary

Other Identifiers

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2021-0582

Identifier Type: -

Identifier Source: org_study_id