Using EEG and ANI to Improve Recovery After Gynecological Surgery
Quality of Recovery After Electroencephalogram and Nociception Level-guided Versus Standard Anesthesia Care in Female Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled Trial
This study is testing if using special brain monitoring during anesthesia can help women recover better after laparoscopic gynecological surgery compared to standard anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT05936671 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of electroencephalogram (EEG) and Analgesia Nociception Index (ANI)-guided anesthesia in enhancing recovery quality following laparoscopic gynecological surgery. Participants will be randomly assigned to either the EEG-and-ANI-guided anesthesia group or a standard care group. The primary outcome will be assessed using the Quality of Recovery (QoR-15) score on the first postoperative day, while secondary outcomes will include various measures such as remifentanil consumption and postoperative pain scores. The study aims to determine if guided anesthesia can lead to better recovery outcomes compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adult women scheduled for laparoscopic gynecological surgeries such as hysterectomy or myomectomy.
Not a fit: Patients with irregular cardiac rhythms, implanted pacemakers, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery experiences for patients undergoing laparoscopic gynecological surgeries.
How similar studies have performed: While the use of EEG and ANI in anesthesia is gaining interest, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul and 1 other locations
- GangnamSeverance Hospital — Seoul, South Korea (Recruiting)
- Gangnam Severance Hospital — Seoul, South Korea (Not_yet_recruiting)
Study contacts
- Principal investigator: Dong Woo Han, MD,PhD — Gangnam Severance Hospital
- Study coordinator: Sun-Kyung Park, MD,PhD
- Email: mayskpark@gmail.com
- Phone: 821024505924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.