Clinical trial NCT06342570: Quantitative Analysis of EEG Changes in Response to Nociception
Official title: Quantitative Analysis of EEG Changes in Response to Nociception
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients Undergoing Laparoscopic Surgery
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 109
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing laparoscopic surgery

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.


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

Primary outcomes:
measure: Correlation between changes in ANI and EEG band power in response to surgical stimulation.
timeFrame: When the laparoscope is inserted
Secondary outcomes:
measure: Correlation between changes in ANI and EEG band power in response to tracheal intubation
timeFrame: When the tracheal intubation is conducted
measure: Correlation between changes in ANI and EEG connectivity in response to surgical stimulation
timeFrame: When the laparoscope is inserted
measure: Correlation between changes in ANI and EEG connectivity in response to tracheal intubation
timeFrame: When the tracheal intubation is conducted
measure: Correlation between changes in ANI, EEG band power and NRS in response to analgesic administration
timeFrame: When analgesic drug is administered in the PACU.
measure: Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration
timeFrame: When analgesic drug is administered in the PACU.
measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI
timeFrame: From the beginning of surgery to the end of surgery
measure: Differences in EEG connectivity during surgery between groups with large and small changes in ANI
timeFrame: From the beginning of surgery to the end of surgery
measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI
timeFrame: From admission to the PACU to discharge from the PACU
measure: Differences in EEG connectivity during recovery between groups with large and small changes in ANI
timeFrame: From admission to the PACU to discharge from the PACU
measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) depending on the type of inhaled anesthetic
timeFrame: From the beginning of surgery to the end of surgery
measure: Differences in EEG connectivity depending on the type of inhaled anesthetic
timeFrame: From the beginning of surgery to the end of surgery
measure: Differences in ANI depending on the type of inhaled anesthetic
timeFrame: From the beginning of surgery to the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References: