CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in interleukin-6 (IL-6) levels
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants are blinded to group allocation. In the control group, CoreSys monitoring data are recorded but not visible to the anesthesiologist. A second investigator monitors these values and intervenes only for patient safety if predefined thresholds are exceeded.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CoreSys-guided anesthesia
Patients receive total intravenous anesthesia guided by standard clinical and hemodynamic parameters plus CoreSys monitoring indices (brain activity, stress activity, and response to inflammation). Standard monitoring includes non-invasive blood pressure, electrocardiography, pulse oximetry, and capnography. Anesthesia is adjusted according to these parameters.
Intervention: propofol (Drug)
CoreSys-guided anesthesia
Patients receive total intravenous anesthesia guided by standard clinical and hemodynamic parameters plus CoreSys monitoring indices (brain activity, stress activity, and response to inflammation). Standard monitoring includes non-invasive blood pressure, electrocardiography, pulse oximetry, and capnography. Anesthesia is adjusted according to these parameters.
Intervention: CoreSys Monitor (Device)
CoreSys-guided anesthesia
Patients receive total intravenous anesthesia guided by standard clinical and hemodynamic parameters plus CoreSys monitoring indices (brain activity, stress activity, and response to inflammation). Standard monitoring includes non-invasive blood pressure, electrocardiography, pulse oximetry, and capnography. Anesthesia is adjusted according to these parameters.
Intervention: Remifentanil (Target-Controlled Infusion) (Drug)
Standard anesthesia
Patients receive total intravenous anesthesia guided by standard clinical and hemodynamic parameters. Standard monitoring includes non-invasive blood pressure, electrocardiography, pulse oximetry, and capnography. CoreSys monitoring is performed but not visible to the treating anesthesiologist and does not influence clinical management. Data are recorded by a second investigator.
Intervention: propofol (Drug)
Standard anesthesia
Patients receive total intravenous anesthesia guided by standard clinical and hemodynamic parameters. Standard monitoring includes non-invasive blood pressure, electrocardiography, pulse oximetry, and capnography. CoreSys monitoring is performed but not visible to the treating anesthesiologist and does not influence clinical management. Data are recorded by a second investigator.
Intervention: Remifentanil (Target-Controlled Infusion) (Drug)
Outcomes
Primary Outcomes
Change in interleukin-6 (IL-6) levels
Time Frame: Baseline (pre-induction), end of surgery, and 24 hours postoperatively
Differences in serum interleukin-6 (IL-6) levels between baseline (preoperative), end of surgery, and 24 hours postoperatively, comparing CoreSys-guided anesthesia versus standard anesthesia.
Change in cortisol levels
Time Frame: Baseline (pre-induction), end of surgery, and 24 hours postoperatively
Differences in serum cortisol levels between baseline (preoperative), end of surgery, and 24 hours postoperatively, comparing CoreSys-guided anesthesia versus standard anesthesia.
Change in blood glucose levels
Time Frame: Baseline (pre-induction), end of surgery, and 24 hours postoperatively
Differences in blood glucose levels between baseline (preoperative), end of surgery, and 24 hours postoperatively, comparing CoreSys-guided anesthesia versus standard anesthesia.
Secondary Outcomes
- Intraoperative mean arterial pressure variability(From baseline (pre-induction) to end of surgery)
- Intraoperative heart rate variability(From baseline (pre-induction) to end of surgery)
- Intraoperative Brain Activity (BA)(From baseline (pre-induction) to end of surgery)
- Intraoperative Stress Activity (SA)(From baseline (pre-induction) to end of surgery)
- Intraoperative burst suppression (BS)(From baseline (pre-induction) to end of surgery)
- Intraoperative Trend of Sepsis and Inflammation (TSI)(From baseline (pre-induction) to end of surgery)
- Intraoperative Analgesia Nociception Index (ANI)(From baseline (pre-induction) to end of surgery)
- Total intraoperative anesthetic consumption(Intraoperative period)
- Early postoperative complications(First 24 hours postoperatively)
Investigators
Mariana Ciancio
Anesthesiologist
Hospital Provincial de Rosario