CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy (CORESTRESS)
30 avril 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Mariana I Ciancio, MD
- Numéro de téléphone: +54 9 341 3007811
- E-mail: marianacianciow@gmail.com
Lieux d'étude
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentine, S2001SBL
- Recrutement
- Hospital Provincial de Rosario
-
Contact:
- Mariana I Ciancio, MD
- Numéro de téléphone: +54 9 341 3007811
- E-mail: marianacianciow@gmail.com
-
Contact:
- E-mail: marianacianciow@gmail.com
-
Chercheur principal:
- Mariana I Ciancio, MD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in interleukin-6 (IL-6) levels
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intraoperative mean arterial pressure variability
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: Intraoperative period
|
Total dose of propofol and remifentanil administered during surgery
|
Intraoperative period
|
|
Early postoperative complications
Délai: First 24 hours postoperatively
|
Incidence of fever, bleeding, nausea, vomiting, and need for transfusion
|
First 24 hours postoperatively
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 janvier 2025
Achèvement primaire (Estimé)
30 mai 2026
Achèvement de l'étude (Estimé)
30 mai 2026
Dates d'inscription aux études
Première soumission
12 avril 2026
Première soumission répondant aux critères de contrôle qualité
30 avril 2026
Première publication (Réel)
6 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 avril 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Conditions pathologiques, signes et symptômes
- Inflammation
- Produits chimiques organiques
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Hydrocarbures
- Hydrocarbures, cyclique
- Acides, acyclique
- Acides carboxyliques
- Hydrocarbures, aromatique
- Pipéridines
- Phénols
- Dérivés de benzène
- Propionates
- Rémifentanil
- Propofol
Autres numéros d'identification d'étude
- 022-1/2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .