CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy

NCT07571473 | Recruiting

• 1 other identifier: 022-1/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Stress Response; Inflammation; Anesthesia; Perioperative Care

Keywords

CoreSys; Surgical Stress; Total Intravenous Anesthesia; Nociception Monitoring; Anesthesia Depth; IL-6

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (2)

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.

Drug: propofol; Device: CoreSys Monitor; Drug: Remifentanil (Target-Controlled Infusion)

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.

Drug: propofol; Drug: Remifentanil (Target-Controlled Infusion)

Interventions

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-guided anesthesia; Standard anesthesia

CoreSys Monitor DEVICE

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

CoreSys-guided anesthesia

Remifentanil (Target-Controlled Infusion) DRUG

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

CoreSys-guided anesthesia; Standard anesthesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-70 years
• Scheduled elective open abdominal hysterectomy in the morning
• Written informed consent

You may not qualify if:

• Refusal to participate
• Significant endocrine/metabolic disease
• Pacemaker or major arrhythmias
• Contraindication to epidural anesthesia

Sponsors & Collaborators

• Hospital Provincial de Rosario: lead
• Coresys Health: collaborator

Study Sites (1)

Hospital Provincial de Rosario

Rosario, Santa Fe Province, S2001SBL, Argentina

RECRUITING

Related Publications (6)

• 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.

  PMID: 21190458 BACKGROUND

• 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.

  PMID: 28341079 RESULT

• 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.

  PMID: 26275092 RESULT

• 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.

  PMID: 28187050 RESULT

• 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.

  PMID: 33456967 RESULT

• 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.

  PMID: 10927999 RESULT

MeSH Terms

Conditions

Inflammation

Interventions

Propofol; Remifentanil

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mariana I Ciancio, MD

CONTACT

+54 9 341 3007811; marianacianciow@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: May 6, 2026
• Study Start: January 8, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)