Quantitative Analysis of EEG Changes in Response to Nociception
1 other identifier
observational
109
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2024
CompletedFirst Posted
Study publicly available on registry
April 2, 2024
CompletedStudy Start
First participant enrolled
April 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
April 30, 2024
April 1, 2024
2.7 years
March 13, 2024
April 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
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.
Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration
When analgesic drug is administered in the PACU.
- +7 more secondary outcomes
Study Arms (1)
There is no group to describe.
There is no group to describe.
Interventions
There is no Intervention name to describe.
Eligibility Criteria
Patients undergoing laparoscopic surgery
You may qualify if:
- Patients aged ≥ 19 undergoing laparoscopic surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GangnamSeverance Hospital
Seoul, South Korea
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 13, 2024
First Posted
April 2, 2024
Study Start
April 21, 2024
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
April 30, 2024
Record last verified: 2024-04