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EEG and ANI Guided Anesthesia and Quality of Recovery

RecruitingNAAges 19 Years - anyFemaleGangnam Severance Hospital
NCT05936671 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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, ฮฑ2-adrenergic agonists, ฮฒ1-adrenergic antagonists, antiarrhythmic agents 4. pregnant or breastfeeding women 5. Patients who are unable to communicate
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What it tests

  • EEG-and-ANI-guided anesthesia
  • standard anesthesia
  • Sevoflurane and remifentanil
  • EEG and ANI
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Where

2 sites
GangnamSeverance Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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