Association of Perioperative Electroencephalography Spectral Analysis With Postoperative Complications

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05818163
Collaborator
(none)
100
1
7
14.2

Study Details

Study Description

Brief 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 pain, nausea and vomiting, restlessness, or delirium in patients undergoing surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: electroencephalography spectral analysis

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Association of Perioperative Electroencephalography Spectral Analysis With Postoperative Complications
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
with postoperative complications

Patients who experience postoperative complications after anesthesia, with symptoms such as pain, nausea and vomiting, delirium, and agitation.

Device: electroencephalography spectral analysis
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.
Other Names:
  • density spectral array
  • patient state index (PSI)
  • without postoperative complications

    Patients who do not experience postoperative complications after anesthesia, free from symptoms such as pain, nausea and vomiting, delirium, and agitation.

    Device: electroencephalography spectral analysis
    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.
    Other Names:
  • density spectral array
  • patient state index (PSI)
  • Outcome Measures

    Primary Outcome Measures

    1. pain in the postanesthesia care unit [up to 2 hours, postanesthesia]

      Visual Analog Scale (VAS) > 3 in the postanesthesia care unit

    2. agitation in the postanesthesia care unit [up to 2 hours, postanesthesia]

      Richmond Agitation-Sedation Scale (RASS)>2 in the postanesthesia care unit

    Secondary Outcome Measures

    1. delirium [up to 2 days, postanesthesia]

      delirium after anesthesia, CAM-ICU

    2. nausea and vomiting [up to 1 day, postanesthesia]

      nausea and vomiting

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Aged 20 years or older.

    2. Patients who received general anesthesia within the our hospital system.

    Exclusion Criteria:
    1. Individuals with suspected infections, such as a fever higher than 38.3℃

    2. Individuals with renal dysfunction, such as those with creatinine levels higher than 1.5 or those who require long-term dialysis

    3. 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

    4. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University, Cancer Center Taipei Taiwan 106

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05818163
    Other Study ID Numbers:
    • 202208066DINA
    First Posted:
    Apr 18, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 18, 2023