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NCT Number: NCT06342570

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.

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Key information

Conditions

Patients Undergoing Laparoscopic Surgery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

There is no Intervention name to describe.

Other

There is no Intervention name to describe.

Primary outcomes

  1. Correlation between changes in ANI and EEG band power in response to surgical stimulation.

    Time frame: When the laparoscope is inserted

    Correlation between changes in ANI and EEG band power in response to surgical stimulation

Secondary outcomes

  1. 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 band power in response to tracheal intubation

  2. 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 surgical stimulation

  3. 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 and EEG connectivity in response to tracheal intubation

  4. 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 band power and NRS in response to analgesic administration

  5. Correlation between changes in ANI, EEG connectivity 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

  6. 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 band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI

  7. 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 connectivity during surgery between groups with large and small changes in ANI

  8. 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 band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI

  9. 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 connectivity during recovery between groups with large and small changes in ANI

  10. 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 band power(Delta, Theta, Alpha, Beta, Gamma) depending on the type of inhaled anesthetic

  11. 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 EEG connectivity depending on the type of inhaled anesthetic

  12. Differences in ANI 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

Study contacts

Contact information is provided by the study sponsor or research team.

Myung Il Bae

CONTACT

[email protected]

82-2-2019-6611

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2024
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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