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

NCT05130333 | Unknown

• 1 other identifier: 2021-0582
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Monitoring; Depth of Anesthesia

Keywords

sedation; Needle electrodes; BIS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation between BIS values and OAA/S score

  Through study completion, an average of 2 year

• 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

Study Arms (1)

Non-cardiac surgery patients under general anesthesia

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

Other: No intervention

Interventions

No intervention OTHER

No intervention

Non-cardiac surgery patients under general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General anesthesia patients undergoing non-cardiac surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location

Study Officials

• Min Yan, Doctor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengjiang Zhang, Doctor

CONTACT

+86 13858007629; zrzfj@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 23, 2021
• Study Start: November 29, 2021
• Primary Completion: October 22, 2022
• Study Completion: February 22, 2023
• Last Updated: December 8, 2021

Record last verified: 2021-10

Locations

CN (1)