CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy
CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy: A Randomized Controlled Trial
Hospital Provincial de Rosario
30 participants
Jan 8, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Female patients aged 18-70 years
- Scheduled elective open abdominal hysterectomy in the morning
- Written informed consent
Exclusion Criteria4
- Refusal to participate
- Significant endocrine/metabolic disease
- Pacemaker or major arrhythmias
- Contraindication to epidural anesthesia
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.
A non-invasive monitoring device that integrates electroencephalographic and autonomic signals to assess hypnotic level, nociception, and intraoperative stress indices.
Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07571473