Esophagogastroduodensocopy (EGD) Procedure
Conditions
Brief summary
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
DRUGOral 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.
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall discomfort of patients | from the start of the endoscopic process to the end of the endoscopic process | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of gagging evaluated by patients | from the start of the endoscopic process to the end of the endoscopic process | 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 | from the start of the endoscopic process to the end of the endoscopic process | 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 | at the end of the endoscopic process | 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 | from the start to the end of the endoscopic process | satisfaction of endoscopist in this process, assessed by NRS 0-10 (0, not satisfied at all; 10 very satisfied). |
Contacts
Primary ContactMin
Outcome results
None listed