Association of Perioperative Electroencephalography Spectral Analysis With Postoperative Complications

NCT05818163 | Unknown

• 1 other identifier: 202208066DINA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Pain; EEG

Keywords

electroencephalography spectral analysis; postoperative complications; anesthesia monitoring

Outcome Measures

Primary Outcomes (2)

• pain in the postanesthesia care unit

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

  up to 2 hours, postanesthesia

• agitation in the postanesthesia care unit

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

  up to 2 hours, postanesthesia

Secondary Outcomes (2)

• delirium

  up to 2 days, postanesthesia

• nausea and vomiting

  up to 1 day, postanesthesia

Study Arms (2)

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

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

Interventions

electroencephalography spectral analysis DEVICE

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.

Also known as: density spectral array, patient state index (PSI)

with postoperative complications; without postoperative complications

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 20 years or older who received general anesthesia within the National Taiwan University Hospital system.

You may qualify if:

• Aged 20 years or older.
• Patients who received general anesthesia within the our hospital system.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University, Cancer Center

Taipei, 106, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain; Postoperative Complications

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Chung Chih Shih, MD

CONTACT

886-2312-3456; s6319138@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)