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EEG and ANI Guided Anesthesia and Quality of Recovery

NCT05936671 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-08-15

No results posted yet for this 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.

Conditions

  • Laparoscopic Gynecological Surgery

Interventions

PROCEDURE

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.

PROCEDURE

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.

DRUG

Sevoflurane and remifentanil

For anesthetic maintenance, balanced anesthesia with sevoflurane inhalation and target controlled infusion of remifentanil will be performed.

DEVICE

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.

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Principal Investigators

  • Dong Woo Han, MD,PhD · Gangnam Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2025-06-19
Completion
2025-06-25

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05936671 on ClinicalTrials.gov