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NCT07571473
CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy
Conditions: Surgical Stress Response, Inflammation, Anesthesia, Perioperative Care
Sex: Female
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Hospital Provincial de Rosario
Location: Hospital Provincial de Rosario Rosario Santa Fe Province
Summary
This randomized controlled trial evaluates whether intraoperative guidance using the CoreSys monitor reduces the surgical stress response in patients undergoing elective open abdominal hysterectomy. Surgical stress involves complex hemodynamic, endocrine, and inflammatory responses that may negatively impact postoperative recovery.
Patients will be randomized to either anesthesia guided by conventional clinical and hemodynamic parameters or anesthesia additionally guided by CoreSys-derived indices of consciousness, nociception, and stress activity. The primary objective is to assess whether CoreSys-guided anesthesia attenuates stress biomarkers, including interleukin-6 (IL-6), cortisol and glycemia.
Eligibility 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
Source: ClinicalTrials.gov (NCT07571473). StuddyBuddy aggregates publicly available trial information.