EEG and ANI Guided Anesthesia and Quality of Recovery

Official title

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

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.

Detailed 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.

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.

Primary outcome measures

• 15-item Quality of Recovery (QoR-15) at postoperative day (POD) #1 [Time frame: 24 hours after the end of surgery]

Secondary outcome measures (12)

• Remifentanil consumption during anesthesia [Time frame: During surgery, from the anesthetic induction to emergence of anesthesia]
• Occurrence of awareness with recall [Time frame: During the operation.]
• Incidence of undesirable intraoperative movement [Time frame: During the operation.]
• Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC) [Time frame: During the operation]
• Intraoperative time ANI <50 [%] [Time frame: During the operation.]
• Intraoperative mean PSi [Time frame: During the operation.]
• Intraoperative mean ANI [Time frame: During the operation.]
• Intraoperative EEG burst suppression [Time frame: During the operation]
• burst suppression ratio [Time frame: During the operation]
• burst suppression duration [Time frame: During the operation]
• Emergence time [Time frame: From time of administration of reversal agents of neuromuscular block until time of extubation, assessed up to 2 hours]
• Intraoperative hypotension [Time frame: During the operation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

South Korea · 2 centers

• GangnamSeverance Hospital — Seoul
• Gangnam Severance Hospital — Seoul

Publications

• Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3. PMID 24937564
• Upton HD, Ludbrook GL, Wing A, Sleigh JW. Intraoperative "Analgesia Nociception Index"-Guided Fentanyl Administration During Sevoflurane Anesthesia in Lumbar Discectomy and Laminectomy: A Randomized Clinical Trial. Anesth Analg. 2017 Jul;125(1):81-90. doi: 10.1213/ANE.0000000000001984. PMID 28598927
• Espitalier F, Idrissi M, Fortier A, Belanger ME, Carrara L, Dakhlallah S, Rivard C, Brulotte V, Zaphiratos V, Loubert C, Godin N, Fortier LP, Verdonck O, Richebe P. "Impact of Nociception Level (NOL) index intraoperative guidance of fentanyl administration on opioid consumption, postoperative pain scores and recovery in patients undergoing gynecological laparoscopic surgery. A randomized controlle PMID 34597955

Identifiers

NCT: NCT05936671 · 3-2023-0116

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗