Oral Ondansetron to Improve Patient Experience of Unsedated Esophagogastroduodenoscopy: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in overall discomfort
研究概览
简要总结
The goal of this interventional pilot study is to explore the feasibility of administering ondansetron prior to esophagogastroduodenoscopy (EGD), and preliminarily test if it can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are:
Is adding oral ondansetron to pre-medication regimen of unsedated EGD safe, easy to conduct, and well-accepted by patients? May taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? May 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 answer the questions above.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for follow-up EGD at PUMCH
- •Signing a written informed consent.
排除标准
- •Contraindications for esophagogastroduodenoscopy.
- •History of upper gastrointestinal tract surgery.
- •With conditions indicated for emergency EGD, such as upper gastrointestinal bleeding
- •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
dyclonine hydrochloride mucilage only
干预措施: dyclonine hydrochloride only (Drug)
oral ondansetron and dyclonine hydrochloride mucilage
干预措施: ondansetron and dyclonine hydrochloride (Drug)
结局指标
主要结局
Change in overall discomfort
时间窗: from the previous endoscopy to 30 minutes after the current endoscopy is finished
All 20 patients were follow-up patients who had unsedated EGD before. They assessed their degree of overall discomfort during the curent examination and the previous examination, both in numeric rating scale (NRS, on a scale from 0 to 10, 0 means no discomfort, 10 means extremely uncomfortable). Change in overall discomfort is the value of the difference between the previous and current NRS (previous-current).
次要结局
- Change in patient gagging intensity(from the previous endoscopic examination to 30 minutes after the current examination is finished.)
- Patient willingness to undergo unsedated EGD again(from start of endoscopy to 30 minutes after the examination is finished)
- Intensity of patient gagging evaluated by endoscopist(from the start of the endoscopic process to the end of the endoscopic process)
- Endoscopist satisfaction for patient cooperation(from the start to the end of the endoscopic process)
研究者
DONG WU
Chief physician of Gastroenterology
Peking Union Medical College Hospital