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Идёт набор NCT07571473

CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy

Без фазы С лечением Surgical Stress Response Inflammation Anesthesia Perioperative Care

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: propofol, CoreSys Monitor, Remifentanil (Target-Controlled Infusion).
Кому может быть актуально
Состояния в реестре: Surgical Stress Response, Inflammation, Anesthesia, Perioperative Care. Базовые параметры: 18 лет — 70 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Аргентина
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат propofol
    Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.
  • Устройство CoreSys Monitor
    A non-invasive monitoring device that integrates electroencephalographic and autonomic signals to assess hypnotic level, nociception, and intraoperative stress indices.
  • Препарат Remifentanil (Target-Controlled Infusion)
    Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.

Первичные конечные точки

  • Change in interleukin-6 (IL-6) levels [Срок оценки: Baseline (pre-induction), end of surgery, and 24 hours postoperatively]
  • Change in cortisol levels [Срок оценки: Baseline (pre-induction), end of surgery, and 24 hours postoperatively]
  • Change in blood glucose levels [Срок оценки: Baseline (pre-induction), end of surgery, and 24 hours postoperatively]
Вторичные конечные точки (9)
  • Intraoperative mean arterial pressure variability [Срок оценки: From baseline (pre-induction) to end of surgery]
  • Intraoperative heart rate variability [Срок оценки: From baseline (pre-induction) to end of surgery]
  • Intraoperative Brain Activity (BA) [Срок оценки: From baseline (pre-induction) to end of surgery]
  • Intraoperative Stress Activity (SA) [Срок оценки: From baseline (pre-induction) to end of surgery]
  • Intraoperative burst suppression (BS) [Срок оценки: From baseline (pre-induction) to end of surgery]
  • Intraoperative Trend of Sepsis and Inflammation (TSI) [Срок оценки: From baseline (pre-induction) to end of surgery]
  • Intraoperative Analgesia Nociception Index (ANI) [Срок оценки: From baseline (pre-induction) to end of surgery]
  • Total intraoperative anesthetic consumption [Срок оценки: Intraoperative period]
  • Early postoperative complications [Срок оценки: First 24 hours postoperatively]

Критерии участия

Критерии включения

  • Female patients aged 18-70 years
  • Scheduled elective open abdominal hysterectomy in the morning
  • Written informed consent

Критерии исключения

  • Refusal to participate
  • Significant endocrine/metabolic disease
  • Pacemaker or major arrhythmias
  • Contraindication to epidural anesthesia

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Аргентина · 1 центр
  • Hospital Provincial de Rosario — Rosario

Публикации

  • 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. PMID 21190458
  • 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. PMID 28341079
  • 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. PMID 26275092
  • 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. PMID 28187050
  • 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. PMID 33456967
  • 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. PMID 10927999

Идентификаторы

NCT: NCT07571473 · 022-1/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗