Quantitative Analysis of EEG Changes in Response to Nociception

Patients Undergoing Laparoscopic Surgery Clinical Trial

Official title:

Quantitative Analysis of EEG Changes in Response to Nociception

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342570
• Other study ID #: 3-2023-0462
• Status: Recruiting
• Start date: April 21, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: Gangnam Severance Hospital
• Contact: Myung Il Bae
• Phone: 82-2-2019-6611
• Email: BMI87[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients Undergoing Laparoscopic Surgery

Intervention

Other:
• There is no Intervention name to describe.
There is no Intervention name to describe.

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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