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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05130333
Enrollment
120
Registered
2021-11-23
Start date
2021-11-29
Completion date
2023-02-22
Last updated
2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depth of Anesthesia, Intraoperative Monitoring

Keywords

sedation, Needle electrodes, BIS

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation coefficientThrough study completion, an average of 2 yearThe correlation coefficient between the BIS value measured by the subdermal needle electrodes and the BIS value measured by the original BIS sensors

Secondary

MeasureTime frameDescription
Correlation between BIS values and OAA/S scoreThrough study completion, an average of 2 yearComparison of the correlation between BIS values measured by two kinds of electrodes and OAA/S
Correlation between BIS values and propofol concentrationThrough study completion, an average of 2 yearCorrelation between BIS values measured by two kinds of electrodes and propofol concentration in blood From Exhaled Gas
Correlation between BIS values and blood pressure and heart rateThrough study completion, an average of 2 yearCorrelation between BIS values measured by two kinds of electrodes and blood pressure and heart rate

Countries

China

Contacts

Primary ContactFengjiang Zhang, Doctor
zrzfj@zju.edu.cn+86 13858007629

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026