Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral ondansetron and dyclonine hydrochloride mucilage, Dyclonine hydrochloride mucilage.
- Who it may be relevant to
- Registry conditions: Esophagogastroduodensocopy (EGD) Procedure. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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. - Drug Dyclonine hydrochloride mucilage
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.
Primary outcome measures
- Overall discomfort of patients [Time frame: from the start of the endoscopic process to the end of the endoscopic process]
Secondary outcome measures (4)
- Intensity of gagging evaluated by patients [Time frame: from the start of the endoscopic process to the end of the endoscopic process]
- Intensity of patient gagging evaluated by endoscopist [Time frame: from the start of the endoscopic process to the end of the endoscopic process]
- Patient willingness to undergo unsedated EGD again [Time frame: at the end of the endoscopic process]
- Endoscopist satisfaction [Time frame: from the start to the end of the endoscopic process]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06729307 · 2024-OUEGD