Идёт набор NCT07245654

Monitoring the Depth of Anesthesia and Nociception During the Induction of General Anesthesia in Pediatric Patients

— Наблюдательное Anaesthesia Anesthesia Depth Monitoring

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Anaesthesia, Anesthesia Depth Monitoring. Базовые параметры: 1 год — 19 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: Чехия
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

Monitoring the Depth of Anesthesia and Nociception During the Induction of General Anesthesia in Pediatric Patients: a Prospective Observational Study

Обзор

Perioperative assessment of adequate depth of anesthesia and analgesia is currently a recommended part of routine anesthesia practice for all surgical procedures. In most cases, it is performed by monitoring and evaluating physiological parameters, which is insufficient, especially for the depth of anesthesia. The depth of anesthesia, when measured with the Conox device, is indicated by the qCON index, the recommended value for anesthesia management is between 40-60. Shallow (above 60) anesthesia may be associated with an increased incidence of perioperative wakefulness episodes, and deeper (below 40) anesthesia may lead to a more frequent occurrence of adverse effects of anesthesia, including emergent delirium in the postoperative period. In addition to assessing the depth of anesthesia, the Conox device also allows for instrumental assessment of analgesia. Inadequate analgesia increases postoperative discomfort and may contribute to an increased incidence of complications in anesthesia and during the postoperative period. Instrumental monitoring of the depth of anesthesia and analgesia increases the safety of anesthesia care. During perioperative care, periods with significant painful stimulation include not only the surgical procedure itself but also airway management during induction of general anesthesia, especially intubation. The hypothesis is - due to the significant painful stimulation during airway management during induction of anesthesia, adequate depth of anesthesia and analgesia may be insufficient and is associated with the patient's clinical response, which may be associated with the occurrence of postoperative delirium.

Подробное описание

After approval by the Ethics Committee of the Brno University Hospital and registration at clinicaltrials.gov, the study will include patients meeting inclusive criteria. Pediatric patients aged 1 year to 19 years who undergo elective surgery under general anesthesia will be included in the study if the expected duration of the operation is more than 30 minutes.

Due to the observational nature of the study (no intervention, the monitoring used is a standard recommended part of anesthesia care), informed consent will not be required. Before induction of anesthesia, the electrodes of the CONOX device will be applied to the patient's forehead according to the manufacturer's recommendations and monitoring of the depth of anesthesia and analgesia will be initiated. Induction of anesthesia will be carried out according to the indications of the anesthesiologist (intravenously or by inhalation). During airway management, the depth of anesthesia and the level of analgesia and the patient's clinical response will be monitored. At the same time, the opioid analgesic used, the method of airway management and the occurrence of a burst suppression ratio will be monitored. Postoperatively, the occurrence of postoperative delirium in the recovery room will be monitored.

Первичные конечные точки

Depth of anesthesia [Срок оценки: Perioperative/Periprocedural]

Вторичные конечные точки (1)

contributing factors [Срок оценки: Perioperative/Periprocedural]

Критерии участия

Критерии включения

Pediatric patients (age 1-19 years) indicated for surgery under general anesthesia with airway management (laryngeal mask, orotracheal intubation, nasotracheal intubation)
CONOX monitoring available