[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572133":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":11,"responsibleParty":35,"collaborators":11,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":11,"eligibilityCriteria":42,"healthyVolunteers":39,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":11,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":11,"overallStatus":55,"whyStopped":11,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":11},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"oral ondansetron and dyclonine hydrochloride mucilage","EXPERIMENTAL",null,[13],"Drug: Oral ondansetron and dyclonine hydrochloride mucilage",{"label":15,"type":6,"description":16,"interventionNames":17},"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.",[18],"Drug: Dyclonine hydrochloride mucilage",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","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.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Dyclonine hydrochloride mucilage","Patients will be instructed to gurgle 10 mL of dyclonine chloride mucilage (0.01 g\u002FmL) and gurgle for 1 minute 15 minutes prior to endoscopic process.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Min","CONTACT","+86 15313350760","minyy19@student.pumc.edu.cn",{"type":36,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100572133","phase-4-ondansetron-combined-with-dyclonine-hydrochloride-to-improve-patient-experience-in-unsedated-esophagogastro-duodenoscopy-100572133",false,"NCT06729307","Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy","Inclusion Criteria:\n\n* Patients indicated for diagnostic EGD: patients with symptoms in which EGD may influence di-agnosis and\u002For disease management, including dysphagia, odynophagia, esophageal refluc symptoms, persistent vomiting, gastrointestinal bleeding, and other upper gastrointestinal symptoms.\n* Signing a written informed consent.\n\nExclusion Criteria:\n\n* Contraindications for esophagogastroduodenoscopy.\n* History of upper gastrointestinal tract surgery.\n* Severe diseases of the heart, kidney, respiratory system, central nervous system, and hematopoietic system.\n* Pregnancy.\n* Neuropsychiatric disorders, severe depression and severe anxiety.\n* Allergy to ondansetron or dyclonine hydrochloride.","ALL","18 Years","45 Years",{"count":47,"type":48},260,"ESTIMATED","INTERVENTIONAL",[51],"PHASE4","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:\n\nDoes 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.\n\nParticipants will be treated with one of the following regimens according to the randomization result:\n\n* Oral ondansetron of 8 mg 2 hours prior to endoscopic process and dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process;\n* dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process.\n\nAfter 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:\n\n* Overall discomfort;\n* Intensity of gagging;\n* Willingness to undergo unsedated EGD again if indicated.",[54],"Esophagogastroduodensocopy (EGD) Procedure","NOT_YET_RECRUITING","2024-12-06",{"date":58,"type":59},"2024-12-11","ACTUAL",{"date":61,"type":48},"2025-01",{"date":63,"type":48},"2026-01",{"name":5,"class":6}]