Intraoperative MonitoringNCT05130333
The Clinical Research of Needle Electrodes Used in Bispectral Index to Monitor the Depth of Anesthesia
An observational study of Intraoperative Monitoring and Depth of Anesthesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Monitoring, Depth of Anesthesia
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2021to 22 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General anesthesia patients undergoing non-cardiac surgery
Who may be able to join
- ASAⅠ~Ⅲ
- Over 18 years old
- Patients undergoing General Anesthesia surgery requiring BIS Monitoring
- Obtained informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, zryanmin@zju.edu.cn
Min Yan, Doctor
About this study
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.
Read the 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
- Being tested
- No intervention
- Keywords
- sedation, Needle electrodes, BIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Non-cardiac surgery patients under general anesthesia | > 18y/o patients undergoing noncardiac surgery with BIS monitoring under general anesthesia. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 2 year
Secondary outcomes (3)
Correlation between BIS values and OAA/S score
Comparison of the correlation between BIS values measured by two kinds of electrodes and OAA/S
Measured: 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
Measured: 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
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start29 Nov 2021 (estimated)
- Primary completion22 Oct 2022 (estimated)
- Study completion22 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative MonitoringStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yan, Doctor, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130333
- Sponsor's protocol ID
- 2021-0582
- Status last verified
- Oct 2021
- First submitted
- 3 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research of Needle Electrodes Used in Bispectral Index to Monitor the Depth of Anesthesia
- ClinicalTrials.gov ID
- NCT05130333
- Acronym / sponsor ID
- 2021-0582
- Conditions
- Intraoperative Monitoring, Depth of Anesthesia
- Keywords
- sedation, Needle electrodes, BIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 29 Nov 2021 (estimated)
- Primary completion
- 22 Oct 2022 (estimated)
- Study completion
- 22 Feb 2023 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-cardiac surgery patients under general anesthesia | – | Other: No intervention> 18y/o patients undergoing noncardiac surgery with BIS monitoring under general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General anesthesia patients undergoing non-cardiac surgery
Key inclusion criteria (4 listed)
- ASAⅠ~Ⅲ
- Over 18 years old
- Patients undergoing General Anesthesia surgery requiring BIS Monitoring
- Obtained informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Non-cardiac surgery patients under general anesthesia |
Primary outcome
Correlation coefficient
Time frame: Through study completion, an average of 2 year
The correlation coefficient between the BIS value measured by the subdermal needle electrodes and the BIS value measured by the original BIS sensors
3 secondary outcomes
Correlation between BIS values and OAA/S score
Time frame: Through study completion, an average of 2 year
Correlation between BIS values and propofol concentration
Time frame: Through study completion, an average of 2 year
Correlation between BIS values and blood pressure and heart rate
Time frame: Through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Yan, Doctor principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Monitoring and Depth of Anesthesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengjiang Zhang, Doctor (+86 13858007629, zrzfj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient (time frame: Through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.