NCT Number: NCT05936671
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.
Interested in participating?
Request Info19 year and older
Female
Interventional
Not applicable
Gangnam Severance Hospital, Seoul, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adult female patients who are scheduled to undergo laparoscopic gynecological surgery.
Exclusion criteria
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.
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.
For anesthetic maintenance, balanced anesthesia with sevoflurane inhalation and target controlled infusion of remifentanil will be performed.
EEG monitoring using SEDline (Masimo, Irvine, California, USA) and Analgesia Nociception Index (ANI; MetroDoloris Medical Systems, Lille, France) monitoring will be performed.
Time frame: 24 hours after the end of surgery
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.
Time frame: During surgery, from the anesthetic induction to emergence of anesthesia
Total remifentanil consumption during anesthesia
Time frame: During the operation.
Occurrence of awareness with recall during surgery, which will be asked at postoperative day #1.
Time frame: During the operation.
Incidence of undesirable intraoperative movement during surgery
Time frame: During the operation
Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)
Time frame: During the operation.
Intraoperative time of ANI value <50 / total duration of surgery (%)
Time frame: During the operation.
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)
Time frame: During the operation.
Intraoperative mean Analgesia Nociception Index (expressed on a non-unit scale of 0-100; 100 indicates maximal relative parasympathetic tone)
Time frame: During the operation
Intraoperative occurrence of burst suppression on electroencephalogram
Time frame: During the operation
Intraoperative burst suppression ratio on electroencephalogram
Time frame: During the operation
duration of burst suppression on electroencephalogram
Time frame: From time of administration of reversal agents of neuromuscular block until time of extubation, assessed up to 2 hours
time between reversal of neuromuscular block and extubation
Time frame: During the operation
Incidence of hypotension during surgery
Time frame: During the operation.
total dose of phenylephrine consumption during surgery
Time frame: scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours
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
Time frame: during the post-anesthesia care unit (PACU) stay, at postoperative day 1, 2
The incidence of post-operative nausea and vomiting
Time frame: At post-operative 24 hours
Patient satisfaction with overall anesthetic management in 11-point scale (0-10), The higher the score, the higher the patient's satisfaction.
Time frame: At post-operative 48 hours
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.
Time frame: from time of the post-anesthesia care unit (PACU) admission to time of discharge from PACU, assessed up to 2 hours
Incidence of shivering, airway obstruction, respiratory depression, sedation
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks
Hospital length of stay
Contact information is provided by the study sponsor or research team.
Gangnam Severance Hospital
Other
Quality of Recovery After Electroencephalogram and Nociception Level-guided Versus Standard Anesthesia Care in Female Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled Trial
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