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Recruiting NCT06342570

Quantitative Analysis of EEG Changes in Response to Nociception

— Observational Patients Undergoing Laparoscopic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: There is no Intervention name to describe..
Who it may be relevant to
Registry conditions: Patients Undergoing Laparoscopic Surgery. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Correlation between changes in ANI and EEG band power in response to surgical stimulation. [Time frame: When the laparoscope is inserted]
Secondary outcome measures (12)
  • Correlation between changes in ANI and EEG band power in response to tracheal intubation [Time frame: When the tracheal intubation is conducted]
  • Correlation between changes in ANI and EEG connectivity in response to surgical stimulation [Time frame: When the laparoscope is inserted]
  • Correlation between changes in ANI and EEG connectivity in response to tracheal intubation [Time frame: When the tracheal intubation is conducted]
  • Correlation between changes in ANI, EEG band power and NRS in response to analgesic administration [Time frame: When analgesic drug is administered in the PACU.]
  • Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From the beginning of surgery to the end of surgery]
  • Differences in EEG connectivity depending on the type of inhaled anesthetic [Time frame: From the beginning of surgery to the end of surgery]
  • Differences in ANI depending on the type of inhaled anesthetic [Time frame: From the beginning of surgery to the end of surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • GangnamSeverance Hospital — Seoul

Identifiers

NCT: NCT06342570 · 3-2023-0462

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗