Effect of Ondansetron on Patient Tolerance, Efficacy and Endoscopist Workload in Unsedated Endoscopy for Upper Gastrointestinal Bleeding

Обзор

The goal of this clinical trial is to evaluate whether intravenous ondansetron can improve patient tolerance and reduce discomfort during unsedated emergency esophagogastroduodenoscopy (EGD). The main questions it aims to answer are: * Does pre-procedural administration of ondansetron improve patient cooperation during emergency EGD? * Does it improve endoscopic field visibility and improve the success rate of initial endoscopic hemostasis？ * Does it reduce the operator's perceived workload or stress? Researchers will compare patients who received intravenous ondansetron with patients who received placebo to see if ondansetron can reduce patient discomfort and improve patient cooperation, therefore improve the quality of the procedure. Participants will receive either intravenous ondansetron and dyclonine hydrochloride mucilage or intravenous saline and dyclonine hydrochloride mucilage prior to the endoscopic procedure.

Вмешательства

• Препарат intravenous ondansetron
  Intravenous administration of 8 mg ondansetron 0.5-1h prior to endoscopic procedure and gurgle 10 ml dyclonine hydrochloride viscous solution (0.01 g/mL) 15 min prior to the endoscopic procedure.
• Препарат Placebo
  Intravenous administration of 8 ml saline 0.5-1h prior to endoscopic procedure and gurgle 10 ml dyclonine hydrochloride viscous solution (0.01 g/mL) 15 min prior to the endoscopic procedure.

Первичные конечные точки

• patient cooperation [Срок оценки: from the beginning to the end of the endoscopic procedure]

Вторичные конечные точки (7)

• gagging intensity of patient [Срок оценки: from the beginning to the end of the endoscopic procedure]
• visualization quality [Срок оценки: During the endoscopic procedure.]
• Success rate of initial endoscopic hemostasis [Срок оценки: from the beginning to the end of the endoscopic procedure]
• Proportion of patients needing repeat endoscopy within 72 hours [Срок оценки: from the time of the endoscopic procedure to 3 days after the endoscopic procedure.]
• Recurrence of UGIB in 7 days [Срок оценки: from the day of the procedure to 7 days after it]
• endoscopist workload [Срок оценки: From the beginning to the end of the endoscopic procedure]
• adverse event [Срок оценки: from the beginning of the intervention to 1 week after the endoscopic procedure.]

Критерии участия

Критерии включения

• Presence of suspected or confirmed upper gastrointestinal bleeding with an indication for emergent endoscopic intervention.
• Capability to provide informed consent.

Критерии исключения

• Presence of any contraindication to upper gastrointestinal endoscopy.
• Concurrent severe primary diseases of the respiratory, cardio-cerebrovascular, renal, central nervous, or hematologic systems.
• Pregnancy.
• Presence of neuropsychiatric disorders, including severe depression or severe anxiety.
• Presence of a known history of cardiac arrhythmia.
• Allergic to dyclonine hydrochloride or ondansetron.

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

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07336680 · ON-UGIB25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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