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CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy (CORESTRESS)

30 de abril de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Argentina
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2001SBL
        • Reclutamiento
        • Hospital Provincial de Rosario
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Mariana I Ciancio, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: propofol
Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.
Dispositivo: CoreSys Monitor
A non-invasive monitoring device that integrates electroencephalographic and autonomic signals to assess hypnotic level, nociception, and intraoperative stress indices.
Droga: Remifentanil (Target-Controlled Infusion)
Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.
Comparador activo: 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.
Droga: propofol
Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.
Droga: Remifentanil (Target-Controlled Infusion)
Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in interleukin-6 (IL-6) levels
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Intraoperative mean arterial pressure variability
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Intraoperative period
Total dose of propofol and remifentanil administered during surgery
Intraoperative period
Early postoperative complications
Periodo de tiempo: First 24 hours postoperatively
Incidence of fever, bleeding, nausea, vomiting, and need for transfusion
First 24 hours postoperatively

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hospital Provincial de Rosario

Colaboradores

Coresys Health

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de enero de 2025

Finalización primaria (Estimado)

30 de mayo de 2026

Finalización del estudio (Estimado)

30 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

12 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de abril de 2026

Publicado por primera vez (Actual)

6 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 022-1/2025

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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