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.
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.
Contraindications for esophagogastroduodenoscopy.
History of upper gastrointestinal tract surgery.
Severe diseases of the heart, kidney, respiratory system, central nervous system, and hematopoietic system.
Pregnancy.
Parallel
Oral ondansetron and dyclonine hydrochloride mucilage
DrugPatients 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.
Dyclonine hydrochloride mucilage
DrugPatients 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.
Overall discomfort of patients
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
Intensity of gagging evaluated by patients
measured by NRS 0-10 (0 none, 10 extremely strong), in a questionnaire given to patients after the endoscopic process is finished
Intensity of patient gagging evaluated by endoscopist
measured by NRS 0-10, (0 none, 10 extremely strong) in a questionnaire given to endoscopists after the endoscopic process is finished
Patient willingness to undergo unsedated EGD again
the willingness of patients to undergo unsedated EGD in the same method again, assessed by NRS 0-10 (0, not willing at all; 10 completely willing).
Endoscopist satisfaction
satisfaction of endoscopist in this process, assessed by NRS 0-10 (0, not satisfied at all; 10 very satisfied).
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This trial is not recruiting at the moment. You can still explore other options:
