CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy (CORESTRESS)
30. april 2026 oppdatert av: Mariana Ciancio, Hospital Provincial de Rosario
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mariana I Ciancio, MD
- Telefonnummer: +54 9 341 3007811
- E-post: marianacianciow@gmail.com
Studiesteder
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentina, S2001SBL
- Rekruttering
- Hospital Provincial de Rosario
-
Ta kontakt med:
- Mariana I Ciancio, MD
- Telefonnummer: +54 9 341 3007811
- E-post: marianacianciow@gmail.com
-
Ta kontakt med:
- E-post: marianacianciow@gmail.com
-
Hovedetterforsker:
- Mariana I Ciancio, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.
A non-invasive monitoring device that integrates electroencephalographic and autonomic signals to assess hypnotic level, nociception, and intraoperative stress indices.
Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.
|
|
Aktiv komparator: 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.
|
Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.
Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in interleukin-6 (IL-6) levels
Tidsramme: Baseline (pre-induction), end of surgery, and 24 hours postoperatively
|
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
Tidsramme: Baseline (pre-induction), end of surgery, and 24 hours postoperatively
|
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
Tidsramme: Baseline (pre-induction), end of surgery, and 24 hours postoperatively
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intraoperative mean arterial pressure variability
Tidsramme: From baseline (pre-induction) to end of surgery
|
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
Tidsramme: From baseline (pre-induction) to end of surgery
|
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)
Tidsramme: From baseline (pre-induction) to end of surgery
|
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)
Tidsramme: From baseline (pre-induction) to end of surgery
|
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)
Tidsramme: From baseline (pre-induction) to end of surgery
|
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)
Tidsramme: From baseline (pre-induction) to end of surgery
|
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)
Tidsramme: From baseline (pre-induction) to end of surgery
|
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
Tidsramme: Intraoperative period
|
Total dose of propofol and remifentanil administered during surgery
|
Intraoperative period
|
|
Early postoperative complications
Tidsramme: First 24 hours postoperatively
|
Incidence of fever, bleeding, nausea, vomiting, and need for transfusion
|
First 24 hours postoperatively
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. januar 2025
Primær fullføring (Antatt)
30. mai 2026
Studiet fullført (Antatt)
30. mai 2026
Datoer for studieregistrering
Først innsendt
12. april 2026
Først innsendt som oppfylte QC-kriteriene
30. april 2026
Først lagt ut (Faktiske)
6. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Patologiske tilstander, tegn og symptomer
- Betennelse
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Hydrokarboner
- Hydrokarboner, syklisk
- Syrer, acyklisk
- Karboksylsyrer
- Hydrokarboner, aromatisk
- Piperidines
- Fenoler
- Benzenderivater
- Propionater
- Remifentanil
- Propofol
Andre studie-ID-numre
- 022-1/2025
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .