CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy (CORESTRESS)
30 de abril de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Mariana I Ciancio, MD
- Número de telefone: +54 9 341 3007811
- E-mail: marianacianciow@gmail.com
Locais de estudo
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentina, S2001SBL
- Recrutamento
- Hospital Provincial de Rosario
-
Contato:
- Mariana I Ciancio, MD
- Número de telefone: +54 9 341 3007811
- E-mail: marianacianciow@gmail.com
-
Contato:
- E-mail: marianacianciow@gmail.com
-
Investigador principal:
- Mariana I Ciancio, MD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in interleukin-6 (IL-6) levels
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Intraoperative mean arterial pressure variability
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: Intraoperative period
|
Total dose of propofol and remifentanil administered during surgery
|
Intraoperative period
|
|
Early postoperative complications
Prazo: First 24 hours postoperatively
|
Incidence of fever, bleeding, nausea, vomiting, and need for transfusion
|
First 24 hours postoperatively
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de janeiro de 2025
Conclusão Primária (Estimado)
30 de maio de 2026
Conclusão do estudo (Estimado)
30 de maio de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
12 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de abril de 2026
Primeira postagem (Real)
6 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Condições Patológicas, Sinais e Sintomas
- Inflamação
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Ácidos, acíclico
- Ácidos carboxílicos
- Hidrocarbonetos, aromáticos
- Piperidinas
- Fenóis
- Derivados de benzeno
- Propionatos
- Remifentanil
- Propofol
Outros números de identificação do estudo
- 022-1/2025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .