Quantitative Analysis of EEG Changes in Response to Nociception

Gangnam Severance Hospital1 site in 1 country109 target enrollmentApril 21, 2024

ConditionsPatients Undergoing Laparoscopic Surgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Patients Undergoing Laparoscopic Surgery
Sponsor: Gangnam Severance Hospital
Enrollment: 109
Locations: 1
Primary Endpoint: Correlation between changes in ANI and EEG band power in response to surgical stimulation.
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will quantify the nociception using Analgesia Nociception Index (ANI) during general anesthesia and analyze the differences in EEG depending on the degree of nociception. Additionally, the investigators will quantify the nociception during recovery and analyze the differences in EEG depending on the degree of nociception.

Registry

clinicaltrials.gov

Start Date

April 21, 2024

End Date

December 30, 2026

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Gangnam Severance Hospital

Responsible Party

Principal Investigator

Dong Woo Han

Professor

Gangnam Severance Hospital

Eligibility Criteria

Inclusion Criteria

•Patients aged ≥ 19 undergoing laparoscopic surgery

Exclusion Criteria

•Patients with arrhythmia
•Patients with pacemaker implantation
•Patients who have received a heart transplant
•Patients taking medications that may affect ANI (antimuscarinics, alpha-agonist, beta blockers, etc.)
•Patients with central nervous system disease (dementia, stroke, epilepsy, brain tumor, psychiatric disease, etc.)
•Patients who cannot understand the consent form

Outcomes

Primary Outcomes

Correlation between changes in ANI and EEG band power in response to surgical stimulation.

Time Frame: When the laparoscope is inserted

Correlation between changes in ANI and EEG band power in response to surgical stimulation

Secondary Outcomes

Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration(When analgesic drug is administered in the PACU.)
Correlation between changes in ANI and EEG band power in response to tracheal intubation(When the tracheal intubation is conducted)
Correlation between changes in ANI and EEG connectivity in response to surgical stimulation(When the laparoscope is inserted)
Correlation between changes in ANI and EEG connectivity in response to tracheal intubation(When the tracheal intubation is conducted)
Correlation between changes in ANI, EEG band power and NRS in response to analgesic administration(When analgesic drug is administered in the PACU.)
Differences in EEG connectivity during recovery between groups with large and small changes in ANI(From admission to the PACU to discharge from the PACU)
Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI(From the beginning of surgery to the end of surgery)
Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI(From admission to the PACU to discharge from the PACU)
Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) depending on the type of inhaled anesthetic(From the beginning of surgery to the end of surgery)
Differences in EEG connectivity during surgery between groups with large and small changes in ANI(From the beginning of surgery to the end of surgery)
Differences in EEG connectivity depending on the type of inhaled anesthetic(From the beginning of surgery to the end of surgery)
Differences in ANI depending on the type of inhaled anesthetic(From the beginning of surgery to the end of surgery)