CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy (CORESTRESS)

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

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Anesthesia; Perioperative Care; Surgical Stress Response
• Intervention / Treatment: Drug: propofol; Device: CoreSys Monitor; Drug: Remifentanil (Target-Controlled Infusion)

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana I Ciancio, MD; Phone Number: +54 9 341 3007811; Email: marianacianciow@gmail.com

Study Locations

• Argentina
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2001SBL
      • Recruiting
      • Hospital Provincial de Rosario
      • Contact: Mariana I Ciancio, MD; Phone Number: +54 9 341 3007811; Email: marianacianciow@gmail.com
      • Contact: Email: marianacianciow@gmail.com
      • Principal Investigator: Mariana I Ciancio, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: propofol; Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.; Device: CoreSys Monitor; A non-invasive monitoring device that integrates electroencephalographic and autonomic signals to assess hypnotic level, nociception, and intraoperative stress indices.; Drug: Remifentanil (Target-Controlled Infusion); Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.
Active Comparator: 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.	Drug: propofol; Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.; Drug: Remifentanil (Target-Controlled Infusion); Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (pre-induction), end of surgery, and 24 hours postoperatively
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.	Baseline (pre-induction), end of surgery, and 24 hours postoperatively
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.	Baseline (pre-induction), end of surgery, and 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline (pre-induction) to end of surgery
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.	From baseline (pre-induction) to end of surgery
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.	From baseline (pre-induction) to end of surgery
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.	From baseline (pre-induction) to end of surgery
Intraoperative burst suppression (BS)	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.	From baseline (pre-induction) to end of surgery
Intraoperative Trend of Sepsis and Inflammation (TSI)	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.	From baseline (pre-induction) to end of surgery
Intraoperative Analgesia Nociception Index (ANI)	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.	From baseline (pre-induction) to end of surgery
Total intraoperative anesthetic consumption	Total dose of propofol and remifentanil administered during surgery	Intraoperative period
Early postoperative complications	Incidence of fever, bleeding, nausea, vomiting, and need for transfusion	First 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Hospital Provincial de Rosario
• Collaborators: Coresys Health

Publications and helpful links

General Publications

• Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.
• Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
• Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
• Abad-Gurumeta A, Ripolles-Melchor J, Casans-Frances R, Calvo-Vecino JM. Monitoring of nociception, reality or fiction? Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):406-414. doi: 10.1016/j.redar.2017.01.009. Epub 2017 Mar 22. English, Spanish.
• Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
• Cusack B, Buggy DJ. Anaesthesia, analgesia, and the surgical stress response. BJA Educ. 2020 Sep;20(9):321-328. doi: 10.1016/j.bjae.2020.04.006. Epub 2020 Jul 21. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: IL-6; Surgical Stress; Total Intravenous Anesthesia; Anesthesia Depth; CoreSys; Nociception Monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Piperidines; Phenols; Benzene Derivatives; Propionates; Remifentanil; Propofol
• Other Study ID Numbers: 022-1/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to the limited sample size and the absence of a formal data-sharing plan. Data will be used solely for the purposes of this study and reported in aggregate form to ensure participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No