Quantitative Analysis of EEG Changes in Response to Nociception

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.

Study Overview

• Status: Recruiting
• Conditions: Patients Undergoing Laparoscopic Surgery
• Intervention / Treatment: Other: There is no Intervention name to describe.

• Study Type: Observational
• Enrollment (Estimated): 109

Contacts and Locations

• Study Contact: Name: Myung Il Bae; Phone Number: 82-2-2019-6611; Email: BMI87@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • GangnamSeverance Hospital
    • Contact: Myung Il Bae; Phone Number: 82-2-2019-6611; Email: BMI87@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
There is no group to describe.	Other: There is no Intervention name to describe.; There is no Intervention name to describe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between changes in ANI and EEG band power in response to surgical stimulation.	Correlation between changes in ANI and EEG band power in response to surgical stimulation	When the laparoscope is inserted

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between changes in ANI and EEG band power in response to tracheal intubation	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	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	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	Correlation between changes in ANI, EEG band power and NRS in response to analgesic administration	When analgesic drug is administered in the PACU.
Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration	Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration	When analgesic drug is administered in the PACU.
Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI	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 connectivity during surgery between groups with large and small changes in ANI	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 band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI	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 connectivity during recovery between groups with large and small changes in ANI	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) depending on the type of inhaled anesthetic	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 depending on the type of inhaled anesthetic	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	Differences in ANI depending on the type of inhaled anesthetic	From the beginning of surgery to the end of surgery

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 18, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 3-2023-0462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No