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| Name | Class |
|---|---|
| Coresys Health | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariana I Ciancio, MD | Contact | +54 9 341 3007811 | marianacianciow@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Provincial de Rosario | Recruiting | Rosario | Santa Fe Province | S2001SBL | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21190458 | Background | 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. | |
| 28341079 | Result | 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. |
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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.
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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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.
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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.
| 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. |
|
| 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 |
| 26275092 | 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. |
| 28187050 | 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. |
| 33456967 | 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. |
| 10927999 | 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. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |