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Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07571473). StuddyBuddy aggregates publicly available trial information.