EEG and ANI Guided Anesthesia and Quality of Recovery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Quality of Recovery After Electroencephalogram and Nociception Level-guided Versus Standard Anesthesia Care in Female Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled Trial

Conditions
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Laparoscopic Gynecological Surgery

Intervention / Treatment
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* Procedure: EEG-and-ANI-guided anesthesia
* Procedure: standard anesthesia
* Drug: Sevoflurane and remifentanil
* Device: EEG and ANI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female patients who are scheduled to undergo laparoscopic gynecological surgery. Total laparoscopic hysterectomy with/without salpingo-oophorectomy Laparoscopic myomectomy Laparoscope-guided salpingo-oophorectomy Laparoscope-guided ovarian cystectomy Laparoscope-guided enucleation of ovarian cyst Exclusion Criteria: 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 Patients who are unable to communicate

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-blinded, parallel-group, randomized clinical study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEG-and-ANI-guided group<br>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: EEG-and-ANI-guided anesthesia<br>* 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.<br>Drug: Sevoflurane and remifentanil<br>* For anesthetic maintenance, balanced anesthesia with sevoflurane inhalation and target controlled infusion of remifentanil will be performed.<br>Device: EEG and ANI<br>* EEG monitoring using SEDline (Masimo, Irvine, California, USA) and Analgesia Nociception Index (ANI; MetroDoloris Medical Systems, Lille, France) monitoring will be performed.<br>|
| Active Comparator: Usual care group<br>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. | Procedure: standard anesthesia<br>* 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.<br>Drug: Sevoflurane and remifentanil<br>* For anesthetic maintenance, balanced anesthesia with sevoflurane inhalation and target controlled infusion of remifentanil will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remifentanil consumption during anesthesia | Total remifentanil consumption during anesthesia | 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. | During the operation. | 
| Incidence of undesirable intraoperative movement | Incidence of undesirable intraoperative movement during surgery | During the operation. | 
| Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC) | Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC) | During the operation | 
| Intraoperative time ANI <50 [%] | Intraoperative time of ANI value <50 / total duration of surgery (%) | 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) | 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) | During the operation. | 
| Intraoperative EEG burst suppression | Intraoperative occurrence of burst suppression on electroencephalogram | During the operation | 
| burst suppression ratio | Intraoperative burst suppression ratio on electroencephalogram | During the operation | 
| burst suppression duration | duration of burst suppression on electroencephalogram | During the operation | 
| Emergence time | time between reversal of neuromuscular block and extubation | 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 | During the operation | 
| Intraoperative phenylephrine consumption | total dose of phenylephrine consumption during surgery | 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 | scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours | 
| The incidence of post-operative nausea and vomiting | The incidence of post-operative nausea and vomiting | 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. | 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. | At post-operative 48 hours | 
| shivering, airway obstruction, respiratory depression, sedation in PACU | Incidence of shivering, airway obstruction, respiratory depression, sedation | 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 | Hospital length of stay | From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks |