EEG and ANI Guided Anesthesia and Quality of Recovery

NCT05936671 | Recruiting

• 1 other identifier: 3-2023-0116
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Laparoscopic Gynecological Surgery

Outcome Measures

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.

  24 hours after the end of surgery

Secondary Outcomes (19)

• Remifentanil consumption during anesthesia

  During surgery, from the anesthetic induction to emergence of anesthesia

• Occurrence of awareness with recall

  During the operation.

• Incidence of undesirable intraoperative movement

  During the operation.

• Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)

  During the operation

• Intraoperative time ANI <50 [%]

  During the operation.

Study Arms (2)

EEG-and-ANI-guided group

EXPERIMENTAL

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; Drug: Sevoflurane and remifentanil; Device: EEG and ANI

Usual care group

ACTIVE COMPARATOR

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; Drug: Sevoflurane and remifentanil

Interventions

EEG-and-ANI-guided anesthesia PROCEDURE

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.

EEG-and-ANI-guided group

standard anesthesia PROCEDURE

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.

Usual care group

Sevoflurane and remifentanil DRUG

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

EEG-and-ANI-guided group; Usual care group

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.

EEG-and-ANI-guided group

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Female patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (2)

GangnamSeverance Hospital

Seoul, 06230, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

NOT YET RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 controlled trial". J Clin Anesth. 2021 Dec;75:110497. doi: 10.1016/j.jclinane.2021.110497. Epub 2021 Sep 28.

  PMID: 34597955 BACKGROUND

MeSH Terms

Interventions

Sevoflurane; Remifentanil; Electroencephalography

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Dong Woo Han, MD,PhD

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun-Kyung Park, MD,PhD

CONTACT

821024505924; mayskpark@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, medical staff who measure outcome variables, surgeons and nurses in the recovery room and wards are blinded so that medical staff and patients do not know the patient's assigned group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, single-blinded, parallel-group, randomized clinical study

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 10, 2023
• Study Start: July 13, 2023
• Primary Completion: June 19, 2025
• Study Completion: June 25, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

KR (2)