Overview
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.
Description
Surgical trauma induces a neuroendocrine and inflammatory stress response characterized by activation of the hypothalamic-pituitary-adrenal axis and release of cytokines such as interleukin-6 (IL-6), a key mediator of acute-phase response and tissue injury severity.
Adequate intraoperative management of hypnosis and analgesia may attenuate this response. However, conventional monitoring relies mainly on indirect clinical and hemodynamic parameters. Advanced monitoring technologies, such as CoreSys, integrate electroencephalographic signals and heart rate variability to provide indices of hypnotic depth (BA), nociception/stress activity (SA), and an Trend of Sepsis and Inflammation (TSI).
This prospective randomized trial aims to determine whether anesthesia guided by CoreSys monitoring reduces intraoperative stress response compared to standard practice. Patients undergoing elective open abdominal hysterectomy will be randomized to either CoreSys-guided anesthesia or standard monitoring. Stress biomarkers (IL-6, cortisol and glycemia) will be measured perioperatively, along with intraoperative hemodynamic variability, anesthetic consumption, and early postoperative outcomes.
Eligibility
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
