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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Republic of Korea
Gangnam Severance Hospital
NOT_YET_RECRUITING
Seoul
GangnamSeverance Hospital
RECRUITING
Seoul
Contact Information
Primary
Sun-Kyung Park, MD,PhD
mayskpark@gmail.com
821024505924
Time Frame
Start Date: 2023-07-13
Estimated Completion Date: 2025-06-25
Participants
Target number of participants: 126
Treatments
Experimental: EEG-and-ANI-guided group
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.
Active_comparator: Usual care group
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.
Related Therapeutic Areas
Sponsors
Leads: Gangnam Severance Hospital

This content was sourced from clinicaltrials.gov