EEG and ANI Guided Anesthesia and Quality of Recovery

Gangnam Severance Hospital126 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

126

Conditions

Interventions

EEG-and-ANI-guided anesthesiaPROCEDURE

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 anesthesiaPROCEDURE

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 remifentanilDRUG

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

EEG and ANIDEVICE

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

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

GangnamSeverance Hospital

Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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

Remifentanil consumption during anesthesia

Total remifentanil consumption during anesthesia

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

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.

Incidence of undesirable intraoperative movement

Incidence of undesirable intraoperative movement during surgery

Time frame: During the operation.

Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)

Time frame: During the operation

Intraoperative time ANI <50 [%]

Intraoperative time of ANI value \<50 / total duration of surgery (%)

Time frame: During the operation.

Intraoperative mean PSi

Intraoperative mean Patient state index (a processed EEG parameter related to a patient's current level of sedation/anesthesia along a scale of 0 to 100, where 100 represents being fully awake)

Time frame: During the operation.

Intraoperative mean ANI

Intraoperative mean Analgesia Nociception Index (expressed on a non-unit scale of 0-100; 100 indicates maximal relative parasympathetic tone)

Time frame: During the operation.

Intraoperative EEG burst suppression

Intraoperative occurrence of burst suppression on electroencephalogram

Time frame: During the operation

burst suppression ratio

Intraoperative burst suppression ratio on electroencephalogram

Time frame: During the operation

burst suppression duration

duration of burst suppression on electroencephalogram

Time frame: During the operation

Emergence time

time between reversal of neuromuscular block and extubation

Time frame: From time of administration of reversal agents of neuromuscular block until time of extubation, assessed up to 2 hours

Intraoperative hypotension

Incidence of hypotension during surgery

Time frame: During the operation

Intraoperative phenylephrine consumption

total dose of phenylephrine consumption during surgery

Time frame: During the operation.

Pain numeric rating scale (NRS)

NRS (0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable ") pain scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours

Time frame: scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours

The incidence of post-operative nausea and vomiting

Time frame: during the post-anesthesia care unit (PACU) stay, at postoperative day 1, 2

Patient satisfaction with anesthetic management

Patient satisfaction with overall anesthetic management in 11-point scale (0-10), The higher the score, the higher the patient's satisfaction.

Time frame: At post-operative 24 hours

Quality of Recovery Questionnaire (15-item Quality of Recovery) at postoperative day #2

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: At post-operative 48 hours

shivering, airway obstruction, respiratory depression, sedation in PACU

Incidence of shivering, airway obstruction, respiratory depression, sedation

Time frame: from time of the post-anesthesia care unit (PACU) admission to time of discharge from PACU, assessed up to 2 hours

Hospital length of stay

Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks

Central Contacts

Sun-Kyung Park, MD,PhD

CONTACT

821024505924 mayskpark@gmail.com

Data from ClinicalTrials.gov

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