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Идёт набор NCT06761573

Bilateral Bispectral Index, Asymmetries and Post-operative Delirium

— Наблюдательное Postoperative Delirium Postoperative Cognitive Dysfunction

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: Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins.
Кому может быть актуально
Состояния в реестре: Postoperative Delirium, Postoperative Cognitive Dysfunction. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
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

Bilateral Bispectral Index and Asymmetries in High Risk Patients for Posteoperative Delirium: An Observational, Prospective, Exploratory Study

Обзор

The primary objective of the study is to describe the value of interhemispheric asymmetry (ASYM), during the different intra- and peri-operative phases, in those patients who develop or do not develop post-operative delirium (POD) during the first 30 post-operative days and postoperative cognitive disfunction (POCD) in the first 90 post-operative days, in a population undergoing head\&neck and plastic surgery with a priori increased probability of POD.

Подробное описание

Values of the study variables will be extract in these specific moments (considering a delay of thirty seconds between the in vivo phenomenon and the instrument): (t1) BIS probe application (t2) 60" before GA administration (t3) 60" after myoresolution (t4) intubation (t5) surgical incision (t6) end of ipnosis (t7) 10 minutes after extubation. Daily follow-up for the first five post-operative days is performed in order to verify the onset of POD and a telephone follow-up at thirty and ninety post-operative days in order to verify the onset of POD / POCD.

CAM scale will be used for the diagnosis of POD; while for the diagnosis of POCD, 6-CIT test will be used, the EQ50 test in the case of tracheostomized patients.

Вмешательства

  • Устройство Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins
    In patients undergoing surgery and general anesthesia, the investigators want to examine -using bilateral BIS monitor- synthetic electroencephalographic differences between the two cerebral hemispheres (ASYM) to evaluate any correlation with the development of POD and POCD in the post-operative period.

Первичные конечные точки

  • Correlation between ASYM (EEG-derived cerebral hemispheric asymmetries) at specific intraoperative timepoints and development of Postoperative Delirium (POD) or Postoperative Cognitive Dysfunction (POCD) [Срок оценки: between 30 and 90 postoperative days]
Вторичные конечные точки (3)
  • Incidence of Postoperative Delirium (POD) and Postoperative Cognitive Dysfunction (POCD) in head&neck and plastic surgery [Срок оценки: follow-up at 5, 30 and 90 postoperative days]
  • Correlation between values of bilateral BSR, bilateral sBIS, bilateral sEMG at specific intraoperative timepoints and development of POD or POCD [Срок оценки: Intraoperative phase: (t1) BIS probe application (t2) 60 seconds before GA administration (t3) 60 seconds after myoresolution (t4) intubation (t5) surgical incision (t6) end of ipnosis (t7) 10 minutes after extubation]
  • Secondar outcomes is to evaluate inter and intra-patient variability of EEG-derived values at specific intraoperative timepoints [Срок оценки: Intraoperative phase: (t1) BIS probe application (t2) 60 seconds before GA administration (t3) 60 seconds after myoresolution (t4) intubation (t5) surgical incision (t6) end of ipnosis (t7) 10 minutes after extubation]

Критерии участия

Критерии включения

-Patients, undergoing head\&neck surgery, who have at least 3 of the following criteria (to establish "a priori" increased risk of POD):

  • Age> 70;
  • Male sex; or ASA III;
  • Smoker;
  • High blood pressure;

Критерии исключения

  • ASA IV, V or ASA IE, IIE, IIIE (patients with anesthetic risk ASA>III and those undergoing urgent-emergency surgery will be excluded from the study);
  • Past positive medical history for:
  • Stroke;
  • Dementia;
  • Cerebral aneurysm;
  • Intracranial mass;
  • Head trauma;
  • Epilepsy;
  • Diabetes mellitus;
  • Previous neurosurgical intervention;
  • Psychiatric illnesses requiring chronic treatment;
  • Patients undergoing surgery in the previous two weeks;
  • Patients whose hospitalization duration is estimated to be less than five days;
  • Lack of understanding of the Italian language or English;
  • Age <18 years.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Италия · 1 центр
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

Публикации

  • Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7. PMID 25928189

Идентификаторы

NCT: NCT06761573 · DELBIS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗