Health TrialsbyHealthPanel

CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy

ConditionsSurgical Stress ResponseInflammationAnesthesiaPerioperative Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorHospital Provincial de Rosario

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-70 years

Scheduled elective open abdominal hysterectomy in the morning

Written informed consent

Disqualifiers

Refusal to participate

Significant endocrine/metabolic disease

Pacemaker or major arrhythmias

Contraindication to epidural anesthesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: CoreSys-guided anesthesiaExperimental treatment 3 interventions
Group B: Standard anesthesiaActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in interleukin-6 (IL-6) levels

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.

Time frame
Baseline (pre-induction), end of surgery, and 24 hours postoperatively
2

Change in cortisol levels

Differences in serum cortisol levels between baseline (preoperative), end of surgery, and 24 hours postoperatively, comparing CoreSys-guided anesthesia versus standard anesthesia.

Time frame
Baseline (pre-induction), end of surgery, and 24 hours postoperatively
3

Change in blood glucose levels

Differences in blood glucose levels between baseline (preoperative), end of surgery, and 24 hours postoperatively, comparing CoreSys-guided anesthesia versus standard anesthesia.

Time frame
Baseline (pre-induction), end of surgery, and 24 hours postoperatively

Secondary outcomes

1

Intraoperative mean arterial pressure variability

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.

Time frame
From baseline (pre-induction) to end of surgery
2

Intraoperative heart rate variability

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.

Time frame
From baseline (pre-induction) to end of surgery
3

Intraoperative Brain Activity (BA)

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.

Time frame
From baseline (pre-induction) to end of surgery
4

Intraoperative Stress Activity (SA)

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.

Time frame
From baseline (pre-induction) to end of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Provincial de Rosario

Lead sponsor

Coresys Health

Collaborator

Source ClinicalTrials.gov
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