EEG and ANI Guided Anesthesia and Quality of Recovery

Laparoscopic Gynecological Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936671
• Other study ID #: 3-2023-0116
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: June 25, 2025

Study information

• Verified date: July 2023
• Source: Gangnam Severance Hospital
• Contact: Sun-Kyung Park, MD,PhD
• Phone: 821024505924
• Email: mayskpark[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: June 25, 2025
• Est. primary completion date: June 19, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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, a2-adrenergic agonists, ß1-adrenergic antagonists, antiarrhythmic agents

4. pregnant or breastfeeding women

5. Patients who are unable to communicate

Related Conditions & MeSH terms

• Laparoscopic Gynecological Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Remifentanil consumption during anesthesia	Total remifentanil consumption during anesthesia	During surgery, from the anesthetic induction to emergence of anesthesia
Secondary	Occurrence of awareness with recall	Occurrence of awareness with recall during surgery, which will be asked at postoperative day #1.	During the operation.
Secondary	Incidence of undesirable intraoperative movement	Incidence of undesirable intraoperative movement during surgery	During the operation.
Secondary	Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)	Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)	During the operation
Secondary	Intraoperative time ANI <50 [%]	Intraoperative time of ANI value <50 / total duration of surgery (%)	During the operation.
Secondary	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.
Secondary	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.
Secondary	Intraoperative EEG burst suppression	Intraoperative occurrence of burst suppression on electroencephalogram	During the operation
Secondary	burst suppression ratio	Intraoperative burst suppression ratio on electroencephalogram	During the operation
Secondary	burst suppression duration	duration of burst suppression on electroencephalogram	During the operation
Secondary	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
Secondary	Intraoperative hypotension	Incidence of hypotension during surgery	During the operation
Secondary	Intraoperative phenylephrine consumption	total dose of phenylephrine consumption during surgery	During the operation.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital length of stay	Hospital length of stay	From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks