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Recruiting NCT07571473

CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy

No phase Interventional Surgical Stress Response Inflammation Anesthesia Perioperative Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: propofol, CoreSys Monitor, Remifentanil (Target-Controlled Infusion).
Who it may be relevant to
Registry conditions: Surgical Stress Response, Inflammation, Anesthesia, Perioperative Care. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Argentina
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in interleukin-6 (IL-6) levels [Time frame: Baseline (pre-induction), end of surgery, and 24 hours postoperatively]
  • Change in cortisol levels [Time frame: Baseline (pre-induction), end of surgery, and 24 hours postoperatively]
  • Change in blood glucose levels [Time frame: Baseline (pre-induction), end of surgery, and 24 hours postoperatively]
Secondary outcome measures (9)
  • Intraoperative mean arterial pressure variability [Time frame: From baseline (pre-induction) to end of surgery]
  • Intraoperative heart rate variability [Time frame: From baseline (pre-induction) to end of surgery]
  • Intraoperative Brain Activity (BA) [Time frame: From baseline (pre-induction) to end of surgery]
  • Intraoperative Stress Activity (SA) [Time frame: From baseline (pre-induction) to end of surgery]
  • Intraoperative burst suppression (BS) [Time frame: From baseline (pre-induction) to end of surgery]
  • Intraoperative Trend of Sepsis and Inflammation (TSI) [Time frame: From baseline (pre-induction) to end of surgery]
  • Intraoperative Analgesia Nociception Index (ANI) [Time frame: From baseline (pre-induction) to end of surgery]
  • Total intraoperative anesthetic consumption [Time frame: Intraoperative period]
  • Early postoperative complications [Time frame: First 24 hours postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Argentina · 1 center
  • Hospital Provincial de Rosario — Rosario

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. PMID 21190458
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07571473 · 022-1/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗