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Clinical Trials in South Korea / NCT05936671
Recruiting Not applicable

EEG and ANI Guided Anesthesia and Quality of Recovery

NCT05936671 · tracked via the Priya Life Science South Korea tracker
Sponsor
Gangnam Severance Hospital
Phase
Not applicable
Started
2023-07-13
Last updated
2026-07-23

Condition(s) studied

Laparoscopic Gynecological Surgery

Investigational drug(s) / intervention(s)

EEG-and-ANI-guided anesthesiastandard anesthesiaSevoflurane and remifentanilEEG and ANI

EEG-and-ANI-guided anesthesia: 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 anesthesia: 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 remifentanil: For anesthetic maintenance, balanced anesthesia with sevoflurane inhalation and target controlled infusion of remifentanil will be performed.

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

Study 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. 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.

Eligibility

Sex
FEMALE
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Adult female patients who are scheduled to undergo laparoscopic gynecological surgery. 1. Total laparoscopic hysterectomy with/without salpingo-oophorectomy 2. Laparoscopic myomectomy 3. Laparoscope-guided salpingo-oophorectomy 4. Laparoscope-guided ovarian cystectomy 5. Laparoscope-guided enucleation of ovarian cyst Exclusion Criteria: 1. Patients with nonregular sinus cardiac rhythm 2. Patients with implanted pacemakers 3. Patients on antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents 4. pregnant or breastfeeding women 5. Patients who are unable to communicate

Primary outcome measure(s)

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

Trial sites (2)

FacilityCityRegionStatus
GangnamSeverance Hospital Seoul Seoul Recruiting
Gangnam Severance Hospital Seoul Seoul Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05936671 on ClinicalTrials.gov ↗ ← All trials in South Korea