Guiding anesthesia with CoreSys during open abdominal hysterectomy
Official title: CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy: A Randomized Controlled Trial
Run by Hospital Provincial de Rosario · NCT07571473 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Hospital Provincial de Rosario Academic / other |
| Locations | 1 site (Rosario, Santa Fe Province) |
| Status | Recruiting |
| Started | January 8, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07571473 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.