Guiding anesthesia with CoreSys during open abdominal hysterectomy
CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy: A Randomized Controlled Trial
NA · Hospital Provincial de Rosario · NCT07571473
This trial will test whether using CoreSys monitoring to guide anesthesia in women having elective open abdominal hysterectomy reduces inflammatory and hormonal stress responses after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Hospital Provincial de Rosario (other) |
| Locations | 1 site (Rosario, Santa Fe Province) |
| Trial ID | NCT07571473 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll women undergoing elective open abdominal hysterectomy and randomize them to standard anesthesia management or to anesthesia guided by CoreSys-derived indices of hypnotic depth (BA), nociception/stress activity (SA), and inflammation trend (TSI). CoreSys integrates EEG features and heart rate variability to provide continuous feedback to the anesthesiologist while both groups receive propofol and remifentanil by target-controlled infusion and standard clinical monitoring. The primary outcomes are perioperative stress biomarkers (IL-6, cortisol, and glycemia) measured at predefined time points, and secondary outcomes include intraoperative hemodynamic variability, anesthetic consumption, and early postoperative recovery measures. The study is single-center at Hospital Provincial de Rosario and excludes patients with major endocrine/metabolic disease, pacemakers or major arrhythmias, or contraindications to epidural anesthesia.
Who should consider this trial
Good fit: Women aged 18–70 scheduled for elective open abdominal hysterectomy in the morning who can give informed consent and do not have major endocrine/metabolic disease, pacemakers/major arrhythmias, or contraindications to epidural anesthesia.
Not a fit: Patients with significant endocrine or metabolic disorders, pacemakers or major arrhythmias, emergency or non-open hysterectomy procedures, or contraindications to epidural anesthesia may not receive benefit from this protocol.
Why it matters
Potential benefit: If successful, CoreSys-guided anesthesia could reduce inflammation and hormonal stress after surgery, potentially improving recovery and reducing postoperative complications.
How similar studies have performed: Related EEG- and nociception-based monitoring approaches have shown mixed but promising results in reducing anesthetic exposure and modulating stress markers, but robust evidence for inflammation reduction with systems like CoreSys remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 18-70 years * Scheduled elective open abdominal hysterectomy in the morning * Written informed consent Exclusion Criteria: * Refusal to participate * Significant endocrine/metabolic disease * Pacemaker or major arrhythmias * Contraindication to epidural anesthesia
Where this trial is running
Rosario, Santa Fe Province
- Hospital Provincial de Rosario — Rosario, Santa Fe Province, Argentina (RECRUITING)
Study contacts
- Study coordinator: Mariana I Ciancio, MD
- Email: marianacianciow@gmail.com
- Phone: +54 9 341 3007811
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.
Conditions: Surgical Stress Response, Inflammation, Anesthesia, Perioperative Care, CoreSys, Surgical Stress, Total Intravenous Anesthesia, Nociception Monitoring