Etomidate Combined With Propofol Versus Propofol for Sedation in High-Altitude Patients During Gastroscopy: a Randomized Multicenter Clinical Trial

Обзор

One of the most common adverse events during sedated gastrointestinal endoscopy is hypoxemia, which can lead to serious consequences. When sedated gastrointestinal endoscopy is performed in high-altitude regions with thin air and lower atmospheric pressure, the risk of hypoxemia in patients significantly increases. Traditionally, propofol is the primary agent for sedation during gastrointestinal endoscopy, offering rapid onset and recovery. However, propofol has many side effects, the most important of which is inhibition of respiration and hypotension. Etomidate has less effect on respiration compared to propofol. But there are also adverse reactions of etomidate such as muscular tremor, nausea and vomiting. This study aims to explore whether the etomidate combined with propofol anesthesia method can reduce the risk of hypoxemia during sedated gastrointestinal endoscopy in high-altitude regions, compared to the traditional propofol anesthesia method .

Вмешательства

• Препарат etomidate combined with propofol
  Patients initially received oxygen via nasal cannula at 5 L/min. All patients underwent routine noninvasive monitoring of blood pressure, ECG, and oxygen saturation. In the EP group, patients received 50 μg fentanyl, followed by a slow intravenous injection of a propofol-etomidate mixture (10 mL:20 mg etomidate + 10 mL:100 mg propofol) at 0.1-0.2 mL/kg. Supplemental doses of 0.05 mL/kg were administered as needed to maintain sedation throughout the procedure.
• Препарат propofol
  Patients initially received oxygen via nasal cannula at 5 L/min. All underwent routine noninvasive monitoring of blood pressure, ECG, and oxygen saturation. In the P group, 50 μg fentanyl was administered, followed by a slow intravenous injection of propofol (1-2 mg/kg) after 3 minutes. Supplemental doses of 0.5 mg/kg were administered as needed to maintain sedation throughout the procedure.

Первичные конечные точки

• The risk of hypoxemia [Срок оценки: during sedated gastrointestinal endoscopy]

Критерии участия

Критерии включения

Age: 18 ≤ years ≤ 70 Patients undergoing pain-free gastroscopy or treatment Endoscopy duration within 30 minutes Informed consent obtained from patient or family member

Критерии исключения

Concomitant diagnosis of cardiac diseases (e.g., heart failure, angina, myocardial infarction, arrhythmia) Diagnosed pulmonary diseases Liver diseases Kidney diseases Intracranial hypertension ASA class III or higher Concomitant active upper respiratory tract infection

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07079176 · 2025-6-20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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