Patients Undergoing Laparoscopic SurgeryNCT06342570
Quantitative Analysis of EEG Changes in Response to Nociception
An observational study of Patients Undergoing Laparoscopic Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patients Undergoing Laparoscopic Surgery
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Apr 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing laparoscopic surgery
Who may be able to join
- Patients aged ≥ 19 undergoing laparoscopic surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
GangnamSeverance Hospital
Seoul
Myung Il Bae, 82-2-2019-6611, BMI87@yuhs.ac
About this study
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.
- Conditions
- Patients Undergoing Laparoscopic Surgery
- Being tested
- There is no Intervention name to describe.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no Intervention name to describe.Other
There is no Intervention name to describe.
| Study group | Role | What they receive |
|---|---|---|
| There is no group to describe. | There is no group to describe. Receives: Other: There is no Intervention name to describe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: When the laparoscope is inserted
Secondary outcomes (12)
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
Measured: When the tracheal intubation is conducted
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
Measured: When the laparoscope is inserted
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
Measured: When the tracheal intubation is conducted
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
Measured: When analgesic drug is administered in the PACU.
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
Measured: 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
Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI
Measured: 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
Differences in EEG connectivity during surgery between groups with large and small changes in ANI
Measured: 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
Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI
Measured: 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
Differences in EEG connectivity during recovery between groups with large and small changes in ANI
Measured: 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
Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) depending on the type of inhaled anesthetic
Measured: From the beginning of surgery to the end of surgery
Differences in EEG connectivity depending on the type of inhaled anesthetic
Differences in EEG connectivity depending on the type of inhaled anesthetic
Measured: From the beginning of surgery to the end of surgery
Differences in ANI depending on the type of inhaled anesthetic
Differences in ANI depending on the type of inhaled anesthetic
Measured: From the beginning of surgery to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start21 Apr 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Laparoscopic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Woo Han, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342570
- Sponsor's protocol ID
- 3-2023-0462
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Analysis of EEG Changes in Response to Nociception
- ClinicalTrials.gov ID
- NCT06342570
- Acronym / sponsor ID
- 3-2023-0462
- Conditions
- Patients Undergoing Laparoscopic Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 21 Apr 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| There is no group to describe. | – | Other: There is no Intervention name to describe.There is no group to describe. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing laparoscopic surgery
Key inclusion criteria (1 listed)
- Patients aged ≥ 19 undergoing laparoscopic surgery
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no Intervention name to describe.There is no Intervention name to describe. | Other | There is no group to describe. |
Primary outcome
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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Undergoing Laparoscopic Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Myung Il Bae (82-2-2019-6611, BMI87@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between changes in ANI and EEG band power in response to surgical stimulation. (time frame: When the laparoscope is inserted). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.