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.
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
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- 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.
South Korea2 sites, 2 recruiting
- Recruiting
GangnamSeverance Hospital
Seoul, Seoul, 06230
Sun-kyung Park
Dong Woo Han, 82-2-2450-5924, mayskpark@yuhs.ac
- Not yet recruiting
Gangnam Severance Hospital
Seoul, Seoul
Sun-Kyung Park, MD, PhD, 82-10-2450-5924, mayskpark@yuhs.ac
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.
- Conditions
- Laparoscopic Gynecological Surgery
- 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 group | Role | What they receive |
|---|---|---|
| EEG-and-ANI-guided group | Experimental | 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. Receives: Procedure: EEG-and-ANI-guided anesthesia; Drug: Sevoflurane and remifentanil; Device: EEG and ANI |
| Usual care group | Active comparator | 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. 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.
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)
Remifentanil consumption during anesthesia
Total remifentanil consumption during anesthesia
Measured: During surgery, from the anesthetic induction to emergence of anesthesia
Occurrence of awareness with recall
Occurrence of awareness with recall during surgery, which will be asked at postoperative day #1.
Measured: During the operation.
Incidence of undesirable intraoperative movement
Incidence of undesirable intraoperative movement during surgery
Measured: During the operation.
Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)
Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)
Measured: During the operation
Intraoperative time ANI <50 [%]
Intraoperative time of ANI value <50 / total duration of surgery (%)
Measured: During the operation.
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.
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.
Intraoperative EEG burst suppression
Intraoperative occurrence of burst suppression on electroencephalogram
Measured: During the operation
burst suppression ratio
Intraoperative burst suppression ratio on electroencephalogram
Measured: During the operation
burst suppression duration
duration of burst suppression on electroencephalogram
Measured: During the operation
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
Intraoperative hypotension
Incidence of hypotension during surgery
Measured: During the operation
Intraoperative phenylephrine consumption
total dose of phenylephrine consumption during surgery
Measured: During the operation.
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
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
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
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
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
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.
- First posted10 Jul 2023
- Study start13 Jul 2023
- Primary completion19 Jun 2027 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Gynecological 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
- 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)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Woo Han, Gangnam Severance Hospital
- Investigators
- Dong Woo Han, MD,PhD, Principal investigator, Gangnam Severance Hospital
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 24937564Upton 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 28598927Espitalier 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05936671
- Acronym / sponsor ID
- 3-2023-0116
- Conditions
- Laparoscopic Gynecological Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 19 Jun 2027 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 10 Jul 2023 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single-blinded, parallel-group, randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| EEG-and-ANI-guided group | Experimental | Procedure: EEG-and-ANI-guided anesthesia, Drug: Sevoflurane and remifentanil, Device: EEG and ANIDuring 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. |
| Usual care group | Active comparator | Procedure: standard anesthesia, Drug: Sevoflurane and remifentanilDuring 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| EEG-and-ANI-guided anesthesiaDuring 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. | Procedure or surgery | EEG-and-ANI-guided group |
| standard anesthesiaDuring 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. | Procedure or surgery | Usual care group |
| Sevoflurane and remifentanilFor anesthetic maintenance, balanced anesthesia with sevoflurane inhalation and target controlled infusion of remifentanil will be performed. | Drug | EEG-and-ANI-guided group, Usual care group |
| EEG and ANIEEG monitoring using SEDline (Masimo, Irvine, California, USA) and Analgesia Nociception Index (ANI; MetroDoloris Medical Systems, Lille, France) monitoring will be performed. | Device | EEG-and-ANI-guided group |
Primary outcome
15-item Quality of Recovery (QoR-15) at postoperative day (POD) #1
Time frame: 24 hours after the end of surgery
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.
19 secondary outcomes
Remifentanil consumption during anesthesia
Time frame: During surgery, from the anesthetic induction to emergence of anesthesia
Occurrence of awareness with recall
Time frame: During the operation.
Incidence of undesirable intraoperative movement
Time frame: During the operation.
Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)
Time frame: During the operation
Intraoperative time ANI <50 [%]
Time frame: During the operation.
Intraoperative mean PSi
Time frame: During the operation.
Intraoperative mean ANI
Time frame: During the operation.
Intraoperative EEG burst suppression
Time frame: During the operation
burst suppression ratio
Time frame: During the operation
burst suppression duration
Time frame: During the operation
Emergence time
Time frame: From time of administration of reversal agents of neuromuscular block until time of extubation, assessed up to 2 hours
Intraoperative hypotension
Time frame: During the operation
Intraoperative phenylephrine consumption
Time frame: During the operation.
Pain numeric rating scale (NRS)
Time frame: scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours
The incidence of post-operative nausea and vomiting
Time frame: during the post-anesthesia care unit (PACU) stay, at postoperative day 1, 2
Patient satisfaction with anesthetic management
Time frame: At post-operative 24 hours
Quality of Recovery Questionnaire (15-item Quality of Recovery) at postoperative day #2
Time frame: At post-operative 48 hours
shivering, airway obstruction, respiratory depression, sedation in PACU
Time frame: from time of the post-anesthesia care unit (PACU) admission to time of discharge from PACU, assessed up to 2 hours
Hospital length of stay
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks
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 23 Jul 2026.
- Background: PubMed 24937564Punjasawadwong 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.
- Background: PubMed 28598927Upton 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.
- Background: PubMed 34597955Espitalier 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.
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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.
Dong Woo Han, MD,PhD principal investigator
Gangnam Severance Hospital
2 sites in 1 country: see every site and its status.
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.