Actively Recruiting

Phase Not Applicable
Age: 19Years +
FEMALE
NCT05936671

EEG and ANI Guided Anesthesia and Quality of Recovery

Led by Gangnam Severance Hospital · Updated on 2024-08-15

126

Participants Needed

2

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

EEG and ANI Guided Anesthesia and Quality of Recovery

Who Can Participate

Age: 19Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult female patients scheduled to undergo laparoscopic gynecological surgery
  • Surgery types include total laparoscopic hysterectomy with or without salpingo-oophorectomy, laparoscopic myomectomy, laparoscope-guided salpingo-oophorectomy, laparoscope-guided ovarian cystectomy, or laparoscope-guided enucleation of ovarian cyst
Not Eligible

You will not qualify if you...

  • Patients with irregular or nonregular sinus cardiac rhythm
  • Patients with implanted pacemakers
  • Patients using antimuscarinic agents, alpha-2 adrenergic agonists, beta-1 adrenergic antagonists, or antiarrhythmic agents
  • Pregnant or breastfeeding women
  • Patients unable to communicate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

GangnamSeverance Hospital

Seoul, South Korea, 06230

Actively Recruiting

2

Gangnam Severance Hospital

Seoul, South Korea

Not Yet Recruiting

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Research Team

S

Sun-Kyung Park, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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EEG and ANI Guided Anesthesia and Quality of Recovery | DecenTrialz