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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
40
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.
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.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Change in overall discomfort
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 NRS 0-10. Change in overall discomfort is the value of the difference between the previous and current NRS (previous-current).
Time frame: from the previous endoscopy to 30 minutes after the current endoscopy is finished
Change in patient gagging intensity
Patients assessed their gagging intensity during the curent examination and the previous examination, both in NRS 0-10. Change in overall discomfort is the value of the difference between the previous and current NRS (previous-current).
Time frame: from the previous endoscopic examination to 30 minutes after the current examination 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).
Time frame: from start of endoscopy to 30 minutes after the examination 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
Time frame: from the start of the endoscopic process to the end of the endoscopic process
Endoscopist satisfaction for patient cooperation
satisfaction of endoscopist for patient cooperation in this process, assessed by NRS 0-10 (0, not satisfied at all; 10 very satisfied).
Time frame: from the start to the end of the endoscopic process
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