CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy
Sponsor: Hospital Provincial de Rosario • ClinicalTrials.gov ID: NCT07571473
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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.
Interventions
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propofol
(Drug)
Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.
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CoreSys Monitor
(Device)
A non-invasive monitoring device that integrates electroencephalographic and autonomic signals to assess hypnotic level, nociception, and intraoperative stress indices.
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Remifentanil (Target-Controlled Infusion)
(Drug)
Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.
Eligibility criteria
Conditions
Locations
- Hospital Provincial de Rosario — Rosario, Santa Fe Province, Argentina
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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