AnesthesiaNCT05818163
Association of Perioperative Electroencephalography Spectral Analysis With Postoperative Complications
An observational study of Anesthesia and Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Using data from electroencephalogram (EEG) obtained through intraoperative depth of anesthesia monitoring devices, combined with clinical symptoms such as postoperative pain and delirium, investigate their correlation and verify whether intraoperative EEG spectral analysis can predict the occurrence of postoperative… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Pain, EEG
- What is being tested?
- electroencephalography spectral analysis
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2023to Dec 2023
- How long will I take part?
- 1 Day
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 20 years or older who received general anesthesia within the National Taiwan University Hospital system.
Who may be able to join
- Aged 20 years or older.
- Patients who received general anesthesia within the our hospital system.
Who cannot join
- Individuals with suspected infections, such as a fever higher than 38.3℃
- Individuals with renal dysfunction, such as those with creatinine levels higher than 1.5 or those who require long-term dialysis
- Individuals with cardiac dysfunction, such as those with NYHA class III or higher heart failure or coronary heart disease Individuals with neurological diseases, such as those with brain tumors, dementia, stroke, or epilepsy
- Vulnerable populations, such as minors (under 20 years of age), pregnant women and fetuses, prisoners, adults who cannot give informed consent, individuals with disabilities, individuals with mental illness, residents of nursing homes or long-term care facilities, or those who may be subject to coercion or unable to make decisions freely.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University, Cancer Center
Taipei, 106
Chung Chih Shih, 023123456, s6319138@gmail.com
About this study
Using data from electroencephalogram (EEG) obtained through intraoperative depth of anesthesia monitoring devices, combined with clinical symptoms such as postoperative pain and delirium, investigate their correlation and verify whether intraoperative EEG spectral analysis can predict the occurrence of postoperative pain, nausea and vomiting, restlessness, or delirium in patients undergoing surgery.
Read the detailed description
Due to the complexity of the original EEG waveforms, previous anesthesia depth monitoring systems only calculated a single index, such as Bispectral index (BIS) or patient state index (PSI), to determine the state under anesthesia. However, a single numerical change may not reflect the true state under anesthesia. By analyzing the original EEG waveforms, more information can be obtained, such as density spectral array (DSA) and power spectral density, which can quantify the energy distribution at various brain wave frequencies. This allows anesthesiologists to determine the effects of medication on brain waves and the effects of surgical stimulation on brain waves during surgery.
After obtaining the signed informed consent form, before inducing general anesthesia in the patient entering the operating room, an anesthesia depth monitoring patch is attached to the forehead, and EEG data during anesthesia is collected using the currently used anesthesia depth monitoring device. The monitoring process starts from the beginning of general anesthesia until the end of the surgery, and the EEG recording is stopped only when the patient wakes up from general anesthesia and leaves the operating room.
By using the original EEG during anesthesia depth monitoring to conduct spectral analysis and combining it with common post-anesthesia adverse symptoms such as pain, nausea and vomiting, delirium, and restlessness, a correlation analysis is conducted between the quantified EEG values and postoperative symptoms. This verifies whether intraoperative EEG spectral analysis can predict the occurrence of postoperative complications.
- Conditions
- Anesthesia, Pain, EEG
- Being tested
- electroencephalography spectral analysis
- Keywords
- electroencephalography spectral analysis, postoperative complications, anesthesia monitoring
- Medical subject headings
- Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalography spectral analysisDevice
Also called density spectral array, patient state index (PSI)
Before inducing general anesthesia in the patient entering the operating room, an anesthesia depth monitoring patch is attached to the forehead, and EEG data during anesthesia is collected using the currently used anesthesia depth monitoring device.
The EEG data is transformed into a frequency and energy distribution and density spectral array (DSA) graph using Fourier transform (FFT) for spectral analysis.
| Study group | Role | What they receive |
|---|---|---|
| with postoperative complications | Patients who experience postoperative complications after anesthesia, with symptoms such as pain, nausea and vomiting, delirium, and agitation. Receives: Device: electroencephalography spectral analysis | |
| without postoperative complications | Patients who do not experience postoperative complications after anesthesia, free from symptoms such as pain, nausea and vomiting, delirium, and agitation. Receives: Device: electroencephalography spectral analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain in the postanesthesia care unit
Visual Analog Scale (VAS) > 3 in the postanesthesia care unit
Measured: up to 2 hours, postanesthesia
agitation in the postanesthesia care unit
Richmond Agitation-Sedation Scale (RASS)>2 in the postanesthesia care unit
Measured: up to 2 hours, postanesthesia
Secondary outcomes (2)
delirium
delirium after anesthesia, CAM-ICU
Measured: up to 2 days, postanesthesia
nausea and vomiting
nausea and vomiting
Measured: up to 1 day, postanesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818163
- Sponsor's protocol ID
- 202208066DINA
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Perioperative Electroencephalography Spectral Analysis With Postoperative Complications
- ClinicalTrials.gov ID
- NCT05818163
- Acronym / sponsor ID
- 202208066DINA
- Conditions
- Anesthesia, Pain, EEG
- Keywords
- electroencephalography spectral analysis, postoperative complications, anesthesia monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Apr 2023 (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.
Using data from electroencephalogram (EEG) obtained through intraoperative depth of anesthesia monitoring devices, combined with clinical symptoms such as postoperative pain and delirium, investigate their correlation and verify whether intraoperative EEG spectral analysis can predict the occurrence of postoperative pain, nausea and vomiting, restlessness, or delirium in patients undergoing surgery.
Detailed description
Due to the complexity of the original EEG waveforms, previous anesthesia depth monitoring systems only calculated a single index, such as Bispectral index (BIS) or patient state index (PSI), to determine the state under anesthesia. However, a single numerical change may not reflect the true state under anesthesia. By analyzing the original EEG waveforms, more information can be obtained, such as density spectral array (DSA) and power spectral density, which can quantify the energy distribution at various brain wave frequencies. This allows anesthesiologists to determine the effects of medication on brain waves and the effects of surgical stimulation on brain waves during surgery.
After obtaining the signed informed consent form, before inducing general anesthesia in the patient entering the operating room, an anesthesia depth monitoring patch is attached to the forehead, and EEG data during anesthesia is collected using the currently used anesthesia depth monitoring device. The monitoring process starts from the beginning of general anesthesia until the end of the surgery, and the EEG recording is stopped only when the patient wakes up from general anesthesia and leaves the operating room.
By using the original EEG during anesthesia depth monitoring to conduct spectral analysis and combining it with common post-anesthesia adverse symptoms such as pain, nausea and vomiting, delirium, and restlessness, a correlation analysis is conducted between the quantified EEG values and postoperative symptoms. This verifies whether intraoperative EEG spectral analysis can predict the occurrence of postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with postoperative complications | – | Device: electroencephalography spectral analysisPatients who experience postoperative complications after anesthesia, with symptoms such as pain, nausea and vomiting, delirium, and agitation. |
| without postoperative complications | – | Device: electroencephalography spectral analysisPatients who do not experience postoperative complications after anesthesia, free from symptoms such as pain, nausea and vomiting, delirium, and agitation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 20 years or older who received general anesthesia within the National Taiwan University Hospital system.
Key inclusion criteria (2 listed)
- Aged 20 years or older.
- Patients who received general anesthesia within the our hospital system.
Key exclusion criteria (4 listed)
- Individuals with suspected infections, such as a fever higher than 38.3℃
- Individuals with renal dysfunction, such as those with creatinine levels higher than 1.5 or those who require long-term dialysis
- Individuals with cardiac dysfunction, such as those with NYHA class III or higher heart failure or coronary heart disease Individuals with neurological diseases, such as those with brain tumors, dementia, stroke, or epilepsy
- Vulnerable populations, such as minors (under 20 years of age), pregnant women and fetuses, prisoners, adults who cannot give informed consent, individuals with disabilities, individuals with mental illness, residents of nursing homes or long-term care facilities, or those who may be subject to coercion or unable to make decisions freely.
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 |
|---|---|---|
| electroencephalography spectral analysisAlso: density spectral array, patient state index (PSI)Before inducing general anesthesia in the patient entering the operating room, an anesthesia depth monitoring patch is attached to the forehead, and EEG data during anesthesia is collected using the currently used anesthesia depth monitoring device. The EEG data is transformed into a frequency and energy distribution and density spectral array (DSA) graph using Fourier transform (FFT) for spectral analysis. | Device | with postoperative complications, without postoperative complications |
Primary outcome
pain in the postanesthesia care unit
Time frame: up to 2 hours, postanesthesia
Visual Analog Scale (VAS) > 3 in the postanesthesia care unit
agitation in the postanesthesia care unit
Time frame: up to 2 hours, postanesthesia
Richmond Agitation-Sedation Scale (RASS)>2 in the postanesthesia care unit
2 secondary outcomes
delirium
Time frame: up to 2 days, postanesthesia
nausea and vomiting
Time frame: up to 1 day, postanesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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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.
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 Anesthesia and Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 4 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 18 Apr 2023. 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 Taiwan. 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 Chung Chih Shih, MD (886-2312-3456, s6319138@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain in the postanesthesia care unit (time frame: up to 2 hours, postanesthesia). The study lists 2 primary outcomes in all. 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 18 Apr 2023.