EEG and ANI Guided Anesthesia and Quality of Recovery

Last updated: August 14, 2024
Sponsor: Gangnam Severance Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

standard anesthesia

Sevoflurane and remifentanil

EEG-and-ANI-guided anesthesia

Clinical Study ID

NCT05936671
3-2023-0116
  • Ages > 19
  • Female

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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Patients with nonregular sinus cardiac rhythm

  2. Patients with implanted pacemakers

  3. Patients on antimuscarinic agents, α2-adrenergic agonists, β1-adrenergicantagonists, antiarrhythmic agents

  4. pregnant or breastfeeding women

  5. Patients who are unable to communicate

Study Design

Total Participants: 126
Treatment Group(s): 4
Primary Treatment: standard anesthesia
Phase:
Study Start date:
July 13, 2023
Estimated Completion Date:
June 25, 2025

Study 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.

Connect with a study center

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • GangnamSeverance Hospital

    Seoul, 06230
    Korea, Republic of

    Active - Recruiting

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