AzTrials
AzTrials

Laparoscopic Gynecological SurgeryNCT05936671

EEG and ANI Guided Anesthesia and Quality of Recovery

A study testing EEG-and-ANI-guided anesthesia, standard anesthesia and Sevoflurane and remifentanil in people with Laparoscopic Gynecological Surgery, run by Gangnam Severance Hospital at 2 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to assess whether electroencephalogram (EEG) and nociception level-guided anesthesia can improve quality of recovery after laparoscopic gynecological surgery compared with standard care. Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Laparoscopic Gynecological Surgery
What is being tested?
EEG-and-ANI-guided anesthesia, standard anesthesia and Sevoflurane and remifentanil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
2 sitesSouth Korea
Study dates
13 Jul 2023to 25 Jun 2027
Phase
Interventional
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult female patients who are scheduled to undergo laparoscopic gynecological surgery.
  • Total laparoscopic hysterectomy with/without salpingo-oophorectomy
  • Laparoscopic myomectomy
  • Laparoscope-guided salpingo-oophorectomy
  • Laparoscope-guided ovarian cystectomy
  • Laparoscope-guided enucleation of ovarian cyst

Who cannot join

  • Patients with nonregular sinus cardiac rhythm
  • Patients with implanted pacemakers
  • Patients on antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents
  • pregnant or breastfeeding women
  • Patients who are unable to communicate

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sun-Kyung Park, MD,PhD contact

821024505924

mayskpark@gmail.com

South Korea2 sites, 2 recruiting
  • GangnamSeverance Hospital

    Seoul, Seoul, 06230

    Sun-kyung Park

    Dong Woo Han, 82-2-2450-5924, mayskpark@yuhs.ac

    Recruiting
  • Gangnam Severance Hospital

    Seoul, Seoul

    Sun-Kyung Park, MD, PhD, 82-10-2450-5924, mayskpark@yuhs.ac

    Not yet recruiting

Other trials in South Korea

About this study

Official title: Quality of Recovery After Electroencephalogram and Nociception Level-guided Versus Standard Anesthesia Care in Female Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled Trial

This study aims to assess whether electroencephalogram (EEG) and nociception level-guided anesthesia can improve quality of recovery after laparoscopic gynecological surgery compared with standard care. Patients will be randomly assigned to either EEG and Analgesia Nociception Index (ANI)-guided anesthesia group (EEG-and-ANI-Guided group) or usual care group (control group). Primary outcome is 15-item Quality of Recovery (QoR-15) score at postoperative day (POD) 1. Secondary outcomes included remifentanil consumption during anesthesia, occurrence of awareness with recall, incidence of undesirable intraoperative movement, emergence time, postoperative pain scores, quality of recovery score at POD 2, and length of hospital stay.

Read the detailed description

Adult women scheduled to undergo laparoscopic gynecologic surgery will be screened for eligibility. Patients will be randomly allocate to either the EEG-and-ANI-guided group or usual care group.

In the guided group, sevoflurane concentration will be titrated according to EEG monitoring. Intraoperative infusion of remifentanil will be titrated by ANI monitoring.

In the usual care group, EEG and ANI sensor will be attached to patients, but EEG and ANI monitor will be blinded to the attending anesthesiologists. The anesthesiologists will provide a standard care of our institution for anesthetic and analgesic titration. In brief, hemodynamic variables and clinical situations will be used to titrate the anesthetic depth and analgesic dose.

Blinded investigator will assess quality of recovery questionnaire-15 at postoperative day 1 and 2.

Being tested
EEG-and-ANI-guided anesthesia, standard anesthesia, Sevoflurane and remifentanil, EEG and ANI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EEG-and-ANI-guided anesthesiaProcedure or surgery

    During anesthetic maintenance, sevoflurane concentration will be titrated according to EEG monitoring. Sevoflurane concentration will be titrated to maintain intraoperative Patient state index (PSi) ≥ 35 and to avoid burst suppression. Intraoperative target-controlled infusion of remifentanil will be titrated to maintain intraoperative ANI between 50 and 70.

  • standard anesthesiaProcedure or surgery

    During anesthetic maintenance, the attending anesthesiologists will provide a routine standard care for anesthetic and analgesic titration. In brief, hemodynamic variables and clinical situations will be used to titrate the sevoflurane concentration and remifentanil infusion rates.

  • Sevoflurane and remifentanilDrug

    For anesthetic maintenance, balanced anesthesia with sevoflurane inhalation and target controlled infusion of remifentanil will be performed.

  • EEG and ANIDevice

    EEG monitoring using SEDline (Masimo, Irvine, California, USA) and Analgesia Nociception Index (ANI; MetroDoloris Medical Systems, Lille, France) monitoring will be performed.

Study groups in NCT05936671
Study groupRoleWhat they receive
EEG-and-ANI-guided groupExperimentalDuring anesthetic maintenance, sevoflurane concentration will be titrated according to EEG monitoring. Sevoflurane concentration will be titrated to maintain intraoperative Patient state index (PSi) ≥ 35 and to avoid burst suppression. Intraoperative target-controlled infusion of remifentanil will be titrated to maintain intraoperative ANI between 50 and 70.
Receives: Procedure: EEG-and-ANI-guided anesthesia; Drug: Sevoflurane and remifentanil; Device: EEG and ANI
Usual care groupActive comparatorDuring anesthetic maintenance, the attending anesthesiologists will provide a routine standard care for anesthetic and analgesic titration. In brief, hemodynamic variables and clinical situations will be used to titrate the sevoflurane concentration and remifentanil infusion rates.
Receives: Procedure: standard anesthesia; Drug: Sevoflurane and remifentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 15-item Quality of Recovery (QoR-15) at postoperative day (POD) #1

    The Korean version of 15-item Quality of Recovery (QoR-15) score. Each item uses an 11-point numeric rating scale. The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.

    Measured: 24 hours after the end of surgery

Secondary outcomes (19)
  1. Remifentanil consumption during anesthesia

    Total remifentanil consumption during anesthesia

    Measured: During surgery, from the anesthetic induction to emergence of anesthesia

  2. Occurrence of awareness with recall

    Occurrence of awareness with recall during surgery, which will be asked at postoperative day #1.

    Measured: During the operation.

  3. Incidence of undesirable intraoperative movement

    Incidence of undesirable intraoperative movement during surgery

    Measured: During the operation.

  4. Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)

    Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)

    Measured: During the operation

  5. Intraoperative time ANI <50 [%]

    Intraoperative time of ANI value <50 / total duration of surgery (%)

    Measured: During the operation.

  6. Intraoperative mean PSi

    Intraoperative mean Patient state index (a processed EEG parameter related to a patient's current level of sedation/anesthesia along a scale of 0 to 100, where 100 represents being fully awake)

    Measured: During the operation.

  7. Intraoperative mean ANI

    Intraoperative mean Analgesia Nociception Index (expressed on a non-unit scale of 0-100; 100 indicates maximal relative parasympathetic tone)

    Measured: During the operation.

  8. Intraoperative EEG burst suppression

    Intraoperative occurrence of burst suppression on electroencephalogram

    Measured: During the operation

  9. burst suppression ratio

    Intraoperative burst suppression ratio on electroencephalogram

    Measured: During the operation

  10. burst suppression duration

    duration of burst suppression on electroencephalogram

    Measured: During the operation

  11. Emergence time

    time between reversal of neuromuscular block and extubation

    Measured: From time of administration of reversal agents of neuromuscular block until time of extubation, assessed up to 2 hours

  12. Intraoperative hypotension

    Incidence of hypotension during surgery

    Measured: During the operation

  13. Intraoperative phenylephrine consumption

    total dose of phenylephrine consumption during surgery

    Measured: During the operation.

  14. Pain numeric rating scale (NRS)

    NRS (0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable ") pain scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours

    Measured: scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours

  15. The incidence of post-operative nausea and vomiting

    The incidence of post-operative nausea and vomiting

    Measured: during the post-anesthesia care unit (PACU) stay, at postoperative day 1, 2

  16. Patient satisfaction with anesthetic management

    Patient satisfaction with overall anesthetic management in 11-point scale (0-10), The higher the score, the higher the patient's satisfaction.

    Measured: At post-operative 24 hours

  17. Quality of Recovery Questionnaire (15-item Quality of Recovery) at postoperative day #2

    Each item uses an 11-point numeric rating scale. The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.

    Measured: At post-operative 48 hours

  18. shivering, airway obstruction, respiratory depression, sedation in PACU

    Incidence of shivering, airway obstruction, respiratory depression, sedation

    Measured: from time of the post-anesthesia care unit (PACU) admission to time of discharge from PACU, assessed up to 2 hours

  19. Hospital length of stay

    Hospital length of stay

    Measured: From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2023
  2. Study start13 Jul 2023
  3. Primary completion19 Jun 2027 (estimated)
  4. Study completion25 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, single-blinded, parallel-group, randomized clinical study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05936671
Sponsor's protocol ID
3-2023-0116
Status last verified
Jul 2026
First submitted
13 Jun 2023
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.

    PubMed 24937564
  • Upton HD, Ludbrook GL, Wing A, Sleigh JW. Intraoperative "Analgesia Nociception Index"-Guided Fentanyl Administration During Sevoflurane Anesthesia in Lumbar Discectomy and Laminectomy: A Randomized Clinical Trial. Anesth Analg. 2017 Jul;125(1):81-90. doi: 10.1213/ANE.0000000000001984.

    PubMed 28598927
  • Espitalier F, Idrissi M, Fortier A, Belanger ME, Carrara L, Dakhlallah S, Rivard C, Brulotte V, Zaphiratos V, Loubert C, Godin N, Fortier LP, Verdonck O, Richebe P. "Impact of Nociception Level (NOL) index intraoperative guidance of fentanyl administration on opioid consumption, postoperative pain scores and recovery in patients undergoing gynecological laparoscopic surgery. A randomized controlled trial". J Clin Anesth. 2021 Dec;75:110497. doi: 10.1016/j.jclinane.2021.110497. Epub 2021 Sep 28.

    PubMed 34597955

Questions about this trial

What is this clinical trial studying?

A study testing EEG-and-ANI-guided anesthesia, standard anesthesia and Sevoflurane and remifentanil in people with Laparoscopic Gynecological Surgery, run by Gangnam Severance Hospital at 2 sites 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 6 inclusion and 5 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 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Sun-Kyung Park, MD,PhD (821024505924, mayskpark@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

15-item Quality of Recovery (QoR-15) at postoperative day (POD) #1 (time frame: 24 hours after the end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936671, which also lists 3 linked publications.

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 23 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
EEG and ANI Guided Anesthesia and Quality of Recovery | AzTrials