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NCT Number: NCT07571473

CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy

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.

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Key information

Conditions

Surgical Stress Response Anesthesia Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative Care

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.

CoreSys Monitor

Device

A non-invasive monitoring device that integrates electroencephalographic and autonomic signals to assess hypnotic level, nociception, and intraoperative stress indices.

Remifentanil (Target-Controlled Infusion)

Drug

Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Intraoperative mean arterial pressure variability

    Time frame: 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.

  2. Intraoperative heart rate variability

    Time frame: 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.

  3. Intraoperative Brain Activity (BA)

    Time frame: 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.

  4. Intraoperative Stress Activity (SA)

    Time frame: 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.

  5. Intraoperative burst suppression (BS)

    Time frame: 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.

  6. Intraoperative Trend of Sepsis and Inflammation (TSI)

    Time frame: 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.

  7. Intraoperative Analgesia Nociception Index (ANI)

    Time frame: 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.

  8. Total intraoperative anesthetic consumption

    Time frame: Intraoperative period

    Total dose of propofol and remifentanil administered during surgery

  9. Early postoperative complications

    Time frame: First 24 hours postoperatively

    Incidence of fever, bleeding, nausea, vomiting, and need for transfusion

Study contacts

Contact information is provided by the study sponsor or research team.

Mariana I Ciancio, MD

CONTACT

[email protected]

+54 9 341 3007811

Sponsors and collaborators

Lead sponsor

Hospital Provincial de Rosario

Other

Collaborators

  • Coresys Health

Registry information

Official study title

CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy: A Randomized Controlled Trial

Acronym: CORESTRESS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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