Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography (BIS-ERCP)
Effect of Bispectral Index (BIS) Monitoring on Postoperative Recovery Profile and Complications in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) Under Deep Sedation: A Randomized Controlled Trial
Endoscopic retrograde cholangiopancreatography (ERCP) requires deep sedation, and propofol is commonly used because of its rapid onset and recovery, but it has a narrow therapeutic window, especially in elderly patients. Bispectral index (BIS) monitoring provides an objective, electroencephalography (EEG)-based measure of sedation depth. This prospective, randomized, single-blind study compares BIS-guided titration of propofol infusion (target BIS 40-60) with standard clinical titration in elderly patients (65 years and older, American Society of Anesthesiologists (ASA) physical status III) undergoing ERCP, with respect to total anesthetic consumption, recovery time, hemodynamic and respiratory complications, and endoscopist satisfaction.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Patients aged 65 years and older, American Society of Anesthesiologists (ASA) physical status III, scheduled for endoscopic retrograde cholangiopancreatography (ERCP) under deep sedation will be randomized 1:1 using sealed envelopes to a bispectral index (BIS)-guided group or a standard care group. All patients receive standardized induction with intravenous (IV) midazolam 0.01 mg/kg, fentanyl 25 mcg and propofol 0.5 mg/kg, followed by a propofol infusion of 50-150 mcg/kg/min.
In the BIS group, the infusion rate is titrated to maintain BIS between 40 and 60, with additional low-dose propofol boluses when needed. In the standard group, BIS electrodes are attached and values are recorded blindly, but the monitor screen is hidden from the anesthesia team; the infusion rate is titrated according to heart rate, blood pressure, peripheral oxygen saturation (SpO2) and clinical signs (patient movement, gagging, swallowing).
ERCP is performed by a single experienced gastroenterologist blinded to group allocation. Heart rate, mean arterial pressure and SpO2 are recorded before and after induction, at 5, 10 and 15 minutes and at the end of the procedure. Recovery is assessed in the post-anesthesia care unit (PACU) using the Modified Aldrete Score.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Van, Турция (Туркие)
- University of Health Sciences, Van Training and Research Hospital
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Контакт:
- Ömer Türk, MD
- Номер телефона: +90 506 979 41 95
- Электронная почта: omer_turk@hotmail.com
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Главный следователь:
- Ömer Türk, MD
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Младший исследователь:
- Sebat İldoğan, MD
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Младший исследователь:
- Cemal Kaçar, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age 65 years or older
- American Society of Anesthesiologists (ASA) physical status III
- Scheduled for endoscopic retrograde cholangiopancreatography (ERCP) under sedation
- Written informed consent obtained from the patient or legal guardian
Exclusion Criteria:
- Refusal to participate or to sign the informed consent form
- Known allergy or hypersensitivity to propofol, midazolam, fentanyl, or to egg or soy components
- Advanced dementia, Alzheimer's disease, prior major cerebrovascular event (stroke), severe cognitive dysfunction or active neurological disease that may affect bispectral index (BIS) measurements
- Local infection, wound, burn or anatomical deformity of the forehead preventing proper placement of BIS electrodes
- ASA IV or higher, hemodynamic instability (shock) or need for active resuscitation before the procedure
- Severe hearing or speech impairment or psychiatric disease preventing assessment with clinical recovery scales
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: BIS-Guided Sedation
Propofol infusion during ERCP is titrated to a target BIS of 40-60 using real-time bispectral index monitoring. |
After standardized induction (midazolam 0.01 mg/kg, fentanyl 25 mcg, propofol 0.5 mg/kg IV), the propofol infusion (50-150 mcg/kg/min) is titrated according to real-time bispectral index (BIS) values to maintain a target BIS of 40-60, with additional low-dose propofol boluses when needed. |
|
Активный компаратор: Standard Clinical Sedation
Propofol infusion during ERCP is titrated according to standard monitoring and clinical signs; BIS values are recorded but hidden from the anesthesia team. |
After the same standardized induction, the propofol infusion (50-150 mcg/kg/min) is titrated according to standard monitoring (heart rate, blood pressure, SpO2) and clinical signs (movement, gagging, swallowing). BIS electrodes are attached and values are recorded, but the BIS screen is hidden from the anesthesia team. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Total Propofol Consumption
Временное ограничение: From induction of sedation to the end of the ERCP procedure
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Total amount of propofol (mg) administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure, including induction, infusion and additional boluses. |
From induction of sedation to the end of the ERCP procedure
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gastroenterologist Satisfaction
Временное ограничение: Immediately after the end of the ERCP procedure
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Procedural comfort and satisfaction rated by the gastroenterologist, who is blinded to group allocation, on a 5-point Likert scale (1 = very poor, 5 = very good). |
Immediately after the end of the ERCP procedure
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Heart Rate
Временное ограничение: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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Heart rate (beats per minute) measured by standard electrocardiographic monitoring. |
Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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Incidence of Sedation-Related Complications
Временное ограничение: From induction of sedation to the end of the ERCP procedure
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Number of participants with hypoxia (peripheral oxygen saturation, SpO2 < 90%), hypotension (mean arterial pressure < 65 mmHg or > 20% decrease from baseline) or bradycardia (heart rate < 50 beats per minute) during the procedure. |
From induction of sedation to the end of the ERCP procedure
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Number of Additional Propofol Boluses
Временное ограничение: From induction of sedation to the end of the ERCP procedure
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Number of additional propofol bolus doses given for signs of inadequate sedation (gagging, swallowing, patient movement) during the procedure. |
From induction of sedation to the end of the ERCP procedure
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Time to Discharge Readiness From the Post-Anesthesia Care Unit
Временное ограничение: From the end of the procedure, up to 2 hours
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Time (minutes) from the end of the procedure until the patient meets post-anesthesia care unit (PACU) discharge criteria according to the Modified Aldrete Score. |
From the end of the procedure, up to 2 hours
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Need for Airway Intervention
Временное ограничение: From induction of sedation to the end of the ERCP procedure
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Number of participants requiring any airway intervention during sedation, recorded by the highest level required: chin lift/jaw thrust, bag-mask ventilation, insertion of an oral/nasal airway or supraglottic device, or endotracheal intubation. |
From induction of sedation to the end of the ERCP procedure
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Mean Arterial Pressure
Временное ограничение: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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Mean arterial pressure (millimeters of mercury, mmHg) measured by non-invasive blood pressure monitoring. |
Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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Peripheral Oxygen Saturation
Временное ограничение: Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
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Peripheral oxygen saturation (SpO2, percentage) measured by pulse oximetry. |
Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure
|
Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Kamel Y, Sasa N, Naguib M, Yassen KA, Sayed E. Bispectral Index Guidance Reduced Target Plasma Propofol Concentration During ERCP in Patients with Liver Cirrhosis. Turk J Anaesthesiol Reanim. 2024 Oct 30;52(5):169-179. doi: 10.4274/TJAR.2024.241635.
- Inal FY, Daskaya H, Yilmaz Y, Kocoglu H. Evaluation of bispectral index monitoring efficacy in endoscopic patients who underwent retrograde cholangiopancreatography and received sedoanalgesia. Wideochir Inne Tech Maloinwazyjne. 2020 Jun;15(2):358-365. doi: 10.5114/wiitm.2020.93461. Epub 2020 Mar 4.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2026/07-01
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Individual participant data will not be shared publicly. De-identified data may be made available by the corresponding author upon reasonable request.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .