Quantitative Analysis of EEG Changes in Response to Nociception

Recruiting

• Conditions: Patients Undergoing Laparoscopic Surgery
• Interventions: Other: There is no Intervention name to describe.

• Registration Number: NCT06342570
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-28
• Status Verified: 2024-04
• Study First Posted: 2024-04-02
• Study Start: 2024-04-21
• Last Update Submitted: 2024-04-28
• Last Update Posted: 2024-04-30
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Patients aged ≥ 19 undergoing laparoscopic surgery

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
There is no group to describe.	There is no Intervention name to describe.	There is no group to describe.

Primary Outcome Measures

Name	Time	Method
Correlation between changes in ANI and EEG band power in response to surgical stimulation.	When the laparoscope is inserted	Correlation between changes in ANI and EEG band power in response to surgical stimulation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of