Health TrialsbyHealthPanel

EEG and ANI Guided Anesthesia and Quality of Recovery

ConditionLaparoscopic Gynecological Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19+
SponsorGangnam Severance Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Total laparoscopic hysterectomy with/without salpingo-oophorectomy

Laparoscopic myomectomy

Laparoscope-guided salpingo-oophorectomy

Laparoscope-guided ovarian cystectomy

Disqualifiers

Patients with nonregular sinus cardiac rhythm

Patients with implanted pacemakers

Patients on antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents

pregnant or breastfeeding women

Trial design

Design model

Parallel

Treatments tested in this trial

  • EEG-and-ANI-guided anesthesia

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Drug

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

  • EEG and ANI

    Device

    EEG monitoring using SEDline (Masimo, Irvine, California, USA) and Analgesia Nociception Index (ANI; MetroDoloris Medical Systems, Lille, France) monitoring will be performed.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: EEG-and-ANI-guided groupExperimental treatment 3 interventions
Group B: Usual care groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

15-item Quality of Recovery (QoR-15) at postoperative day (POD) #1

The Korean version of 15-item Quality of Recovery (QoR-15) score. Each item uses an 11-point numeric rating scale. The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.

Time frame
24 hours after the end of surgery

Secondary outcomes

1

Remifentanil consumption during anesthesia

Total remifentanil consumption during anesthesia

Time frame
During surgery, from the anesthetic induction to emergence of anesthesia
2

Occurrence of awareness with recall

Occurrence of awareness with recall during surgery, which will be asked at postoperative day #1.

Time frame
During the operation.
3

Incidence of undesirable intraoperative movement

Incidence of undesirable intraoperative movement during surgery

Time frame
During the operation.
4

Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)

Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)

Time frame
During the operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gangnam Severance Hospital

Lead sponsor

Source ClinicalTrials.gov
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