Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 260
- 主要终点
- Overall discomfort of patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
oral ondansetron and dyclonine hydrochloride mucilage
干预措施: Oral ondansetron and dyclonine hydrochloride mucilage (Drug)
dyclonine hydrochloride mucilage only
Patients are treated with only topical pharyngeal anesthesia (dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process), with no antiemetic drug or placebo.
干预措施: Dyclonine hydrochloride mucilage (Drug)
结局指标
主要结局
Overall discomfort of patients
时间窗: from the start of the endoscopic process to the end of the endoscopic process
measured by NRS 0-10 (0 no discomfort, 10 as uncomfortable as can be), in a questionnaire given to patients after the endoscopic process is finished
次要结局
- Intensity of gagging evaluated by patients(from the start of the endoscopic process to the end of the endoscopic process)
- Intensity of patient gagging evaluated by endoscopist(from the start of the endoscopic process to the end of the endoscopic process)
- Patient willingness to undergo unsedated EGD again(at the end of the endoscopic process)
- Endoscopist satisfaction(from the start to the end of the endoscopic process)