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EEG and ANI Guided Anesthesia and Quality of Recovery

EEG and ANI Guided Anesthesia and Quality of Recovery

Recruiting
19 years and older
Female
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details
    Laparoscopic Gynecological Surgery

NCT05936671

Gangnam Severance Hospital

26 January 2024

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