Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy

Обзор

The goal of this clinical trial is to learn if administering ondansetron prior to esophagogastroduodenoscopy (EGD) can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are: Does taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? Does taking ondansetron prior to EGD reduce the intensity of patient gagging and nausea, and the incidence of vomiting ? Researchers will compare premedication of oral ondasetron and topical pharyngeal anesthesia (dyclonine hydrochloride mucilage) with topical pharyngeal anesthesia only to see if ondansetron can exert the above-mentioned effects. Participants will be treated with one of the following regimens according to the randomization result: * Oral ondansetron of 8 mg 2 hours prior to endoscopic process and dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process; * dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process. After the endoscopic process is finished, patients will be asked to fill in a questionnaire that contains the following items, all measured by NRS 0-10: * Overall discomfort; * Intensity of gagging; * Willingness to undergo unsedated EGD again if indicated.

Вмешательства

• Препарат Oral ondansetron and dyclonine hydrochloride mucilage
  Patients will take 8 mg oral ondansetron 2 hours prior to EGD process in addition to dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to EGD process.
• Препарат Dyclonine hydrochloride mucilage
  Patients will be instructed to gurgle 10 mL of dyclonine chloride mucilage (0.01 g/mL) and gurgle for 1 minute 15 minutes prior to endoscopic process.

Первичные конечные точки

• Overall discomfort of patients [Срок оценки: from the start of the endoscopic process to the end of the endoscopic process]

Вторичные конечные точки (4)

• Intensity of gagging evaluated by patients [Срок оценки: from the start of the endoscopic process to the end of the endoscopic process]
• Intensity of patient gagging evaluated by endoscopist [Срок оценки: from the start of the endoscopic process to the end of the endoscopic process]
• Patient willingness to undergo unsedated EGD again [Срок оценки: at the end of the endoscopic process]
• Endoscopist satisfaction [Срок оценки: from the start to the end of the endoscopic process]

Критерии участия

Критерии включения

• Patients indicated for diagnostic EGD: patients with symptoms in which EGD may influence di-agnosis and/or disease management, including dysphagia, odynophagia, esophageal refluc symptoms, persistent vomiting, gastrointestinal bleeding, and other upper gastrointestinal symptoms.
• Signing a written informed consent.

Критерии исключения

• Contraindications for esophagogastroduodenoscopy.
• History of upper gastrointestinal tract surgery.
• Severe diseases of the heart, kidney, respiratory system, central nervous system, and hematopoietic system.
• Pregnancy.
• Neuropsychiatric disorders, severe depression and severe anxiety.
• Allergy to ondansetron or dyclonine hydrochloride.

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

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06729307 · 2024-OUEGD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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