Набор скоро начнётся NCT07232160

Is Density Spectral Array Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone

— Наблюдательное Awareness During General Anesthesia

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: Depth of anesthesia monitoring using processed EEG.
Кому может быть актуально: Состояния в реестре: Awareness During General Anesthesia. Базовые параметры: от 65 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: Австралия
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

Is DSA Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone in Detecting Emergence From Propofol and Opiate Anesthesia? A Prospective Observational Study in Patients Older Than 65 Years?

Обзор

A study to evaluate the use of density spectral array display in comparison with Bispectral index in a clinical setting.

Подробное описание

Propofol-based total intravenous anesthesia (TIVA) is a popular general anesthesia (GA) technique with an increased risk of unintended awareness under GA, which can be a devastating and life-changing complication. Age-related changes may impact the performance of EEG-derived depth of anesthesia indices in those older than 65 years, particularly in the presence of cognitive disorders.

Hypothesis: In comparison to monitor 1 (BIS only), monitor 2 (DSA + BIS) will have higher sensitivity and specificity to detect recovery

Objectives:

Investigators will prospectively measure the sensitivity and specificity of monitor 1 versus monitor 2 in patients older than 65 years receiving propofol-based TIVA.

Methods:

Investigators will recruit 70 participants from the Royal Brisbane and Women's Hospital (RBWH) who are aged 65 years or older and scheduled for elective endovascular or endoscopic urologic procedures.

Investigators aim to determine whether the display of DSA can enhance the sensitivity and specificity of depth of anesthesia monitors in detecting sudden changes in anesthetic depth in older patients. This may enhance the detection of inadequate administration or delivery of propofol and may lower the incidence of unintended awareness under general anesthesia in that age group.

Вмешательства

Устройство Depth of anesthesia monitoring using processed EEG
Comparison of processed EEG monitor (Bispectral index) with and without Density spectral array

Первичные конечные точки

aim [Срок оценки: In the perioperative period, following the cessation of anesthesia, the patient begins to emerge from a deep anesthetic state to a lighter state and then regains consciousness. The time frame is usually in minutes, but varies depending on various factors]
Primary aim [Срок оценки: In the perioperative period, time following the cessation of intravenous anesthesia after the procedure; emergence from anesthesia usually takes place over a few minutes to hours.]

Критерии участия

Критерии включения

Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA.
Procedures in which a DoA monitor can be applied to the forehead.
Patients receiving intravenous propofol and opiate anaesthesia using supraglottic airway device.
Patient able to provide informed consent.