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Clinical Trials/NCT07571473
NCT07571473RecruitingNot Applicable

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

Hospital Provincial de Rosario1 site in 1 country30 target enrollmentStarted: January 8, 2025Last updated:
Conditions
Interventions
Drugs

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

Experimental

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

Experimental

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

Experimental

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

Active Comparator

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

Active Comparator

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

Sponsor
Hospital Provincial de Rosario
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mariana Ciancio

Anesthesiologist

Hospital Provincial de Rosario

Study Sites (1)

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