EEG and ANI Guided Anesthesia and Quality of Recovery

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Laparoscopic Gynecological Surgery

Treatments: Procedure: EEG-and-ANI-guided anesthesia; Device: EEG and ANI; Procedure: standard anesthesia; Drug: Sevoflurane and remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT05936671

3-2023-0116

Details and patient eligibility

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.

Full description

Adult women scheduled to undergo laparoscopic gynecologic surgery will be screened for eligibility. Patients will be randomly allocate to either the EEG-and-ANI-guided group or usual care group.

In the guided group, sevoflurane concentration will be titrated according to EEG monitoring. Intraoperative infusion of remifentanil will be titrated by ANI monitoring.

In the usual care group, EEG and ANI sensor will be attached to patients, but EEG and ANI monitor will be blinded to the attending anesthesiologists. The anesthesiologists will provide a standard care of our institution for anesthetic and analgesic titration. In brief, hemodynamic variables and clinical situations will be used to titrate the anesthetic depth and analgesic dose.

Blinded investigator will assess quality of recovery questionnaire-15 at postoperative day 1 and 2.

Enrollment: 126 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents
4. pregnant or breastfeeding women
5. Patients who are unable to communicate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 2 patient groups

EEG-and-ANI-guided group

Experimental group

Description:

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.

Treatment:

Drug: Sevoflurane and remifentanil

Device: EEG and ANI

Procedure: EEG-and-ANI-guided anesthesia

Usual care group

Active Comparator group

Description:

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.

Treatment:

Drug: Sevoflurane and remifentanil

Procedure: standard anesthesia