Anesthesia, Inflammation, Perioperative Care, Surgical Stress Response
Conditions
Keywords
CoreSys, Surgical Stress, Total Intravenous Anesthesia, Nociception Monitoring, Anesthesia Depth, IL-6
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.
Interventions
DRUGpropofol
Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.
DEVICECoreSys Monitor
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.
Sponsors
Hospital Provincial de Rosario
Coresys Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
Participants are randomized into two parallel groups. In the intervention group, the anesthesiologist guides anesthesia using standard clinical and hemodynamic parameters in addition to CoreSys-derived indices. In the control group, the anesthesiologist guides anesthesia using standard clinical and hemodynamic parameters without access to CoreSys-derived values. CoreSys data are recorded in both groups; however, in the control group, a second investigator monitors these values and intervenes only for patient safety if predefined thresholds are exceeded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in interleukin-6 (IL-6) levels | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative mean arterial pressure variability | From baseline (pre-induction) to end of surgery | Mean arterial pressure measured at predefined time points: baseline (pre-induction), post-intubation, surgical incision, 30, 60, 90, and 120 minutes after surgery start, and at the end of surgery. Variability will be assessed over time and between groups. |
| Intraoperative heart rate variability | From baseline (pre-induction) to end of surgery | Heart rate measured at predefined time points: baseline (pre-induction), post-intubation, surgical incision, 30, 60, 90, and 120 minutes after surgery start, and at the end of surgery. Variability will be assessed over time and between groups. |
| Intraoperative Brain Activity (BA) | From baseline (pre-induction) to end of surgery | Brain Activity (BA) index obtained from CoreSys monitoring, measured at predefined time points: baseline (pre-induction), post-intubation, surgical incision, 30, 60, 90, and 120 minutes after surgery start, and at the end of surgery. |
| Intraoperative Stress Activity (SA) | From baseline (pre-induction) to end of surgery | Stress Activity (SA) index obtained from CoreSys monitoring, measured at predefined time points: baseline (pre-induction), post-intubation, surgical incision, 30, 60, 90, and 120 minutes after surgery start, and at the end of surgery. |
| Intraoperative burst suppression (BS) | From baseline (pre-induction) to end of surgery | Burst suppression values obtained from electroencephalographic monitoring measured at predefined time points: baseline (pre-induction), post-intubation, surgical incision, 30, 60, 90, and 120 minutes after surgery start, and at the end of surgery. |
| Intraoperative Trend of Sepsis and Inflammation (TSI) | From baseline (pre-induction) to end of surgery | Trend of Sepsis and Inflammation (TSI) index obtained from CoreSys monitoring, measured at predefined time points: baseline (pre-induction), post-intubation, surgical incision, 30, 60, 90, and 120 minutes after surgery start, and at the end of surgery. |
| Intraoperative Analgesia Nociception Index (ANI) | From baseline (pre-induction) to end of surgery | ANI values including instantaneous (ANIi) and mean (ANIm) indices measured at predefined time points: baseline (pre-induction), post-intubation, surgical incision, 30, 60, 90, and 120 minutes after surgery start, and at the end of surgery. |
| Total intraoperative anesthetic consumption | Intraoperative period | Total dose of propofol and remifentanil administered during surgery |
| Early postoperative complications | First 24 hours postoperatively | Incidence of fever, bleeding, nausea, vomiting, and need for transfusion |
Countries
Argentina
Contacts
CONTACTMariana I Ciancio, MD
Outcome results
None listed