Clinical trial NCT05936671: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Gynecological Surgery
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 126
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-blinded, parallel-group, randomized clinical study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 15-item Quality of Recovery (QoR-15) at postoperative day (POD) #1
timeFrame: 24 hours after the end of surgery
Secondary outcomes:
measure: Remifentanil consumption during anesthesia
timeFrame: During surgery, from the anesthetic induction to emergence of anesthesia
measure: Occurrence of awareness with recall
timeFrame: During the operation.
measure: Incidence of undesirable intraoperative movement
timeFrame: During the operation.
measure: Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)
timeFrame: During the operation
measure: Intraoperative time ANI <50 [%]
timeFrame: During the operation.
measure: Intraoperative mean PSi
timeFrame: During the operation.
measure: Intraoperative mean ANI
timeFrame: During the operation.
measure: Intraoperative EEG burst suppression
timeFrame: During the operation
measure: burst suppression ratio
timeFrame: During the operation
measure: burst suppression duration
timeFrame: During the operation
measure: Emergence time
timeFrame: From time of administration of reversal agents of neuromuscular block until time of extubation, assessed up to 2 hours
measure: Intraoperative hypotension
timeFrame: During the operation
measure: Intraoperative phenylephrine consumption
timeFrame: During the operation.
measure: Pain numeric rating scale (NRS)
timeFrame: scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours
measure: The incidence of post-operative nausea and vomiting
timeFrame: during the post-anesthesia care unit (PACU) stay, at postoperative day 1, 2
measure: Patient satisfaction with anesthetic management
timeFrame: At post-operative 24 hours
measure: Quality of Recovery Questionnaire (15-item Quality of Recovery) at postoperative day #2
timeFrame: At post-operative 48 hours
measure: shivering, airway obstruction, respiratory depression, sedation in PACU
timeFrame: from time of the post-anesthesia care unit (PACU) admission to time of discharge from PACU, assessed up to 2 hours
measure: Hospital length of stay
timeFrame: From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Dong Woo Han, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.