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EEG and ANI Guided Anesthesia and Quality of Recovery
Sponsor: Gangnam Severance Hospital
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.
Official title: Quality of Recovery After Electroencephalogram and Nociception Level-guided Versus Standard Anesthesia Care in Female Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2023-07-13
Completion Date
2025-06-25
Last Updated
2024-08-15
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (2)
GangnamSeverance Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea