Esophagogastroduodensocopy (EGD) Procedure
Conditions
Brief summary
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.
Interventions
DRUGondansetron and dyclonine hydrochloride
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.
DRUGdyclonine hydrochloride only
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
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients scheduled for follow-up EGD at PUMCH * Signing a written informed consent.
Exclusion criteria
* Contraindications for esophagogastroduodenoscopy. * History of upper gastrointestinal tract surgery. * With conditions indicated for emergency EGD, such as upper gastrointestinal bleeding * 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 |
|---|---|---|
| Change in overall discomfort | from the previous endoscopy to 30 minutes after the current endoscopy is finished | 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 numeric rating scale (NRS, on a scale from 0 to 10, 0 means no discomfort, 10 means extremely uncomfortable). Change in overall discomfort is the value of the difference between the previous and current NRS (previous-current). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient gagging intensity | from the previous endoscopic examination to 30 minutes after the current examination is finished. | Patients assessed their gagging intensity during the curent examination and the previous examination, both in NRS 0-10, 0 means no gagging, 10 means extremely intense gagging. Change in overall discomfort is the value of the difference between the previous and current NRS (previous-current). |
| Patient willingness to undergo unsedated EGD again | from start of endoscopy to 30 minutes after the examination is finished | 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). |
| 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 |
| Endoscopist satisfaction for patient cooperation | from the start to the end of the endoscopic process | satisfaction of endoscopist for patient cooperation in this process, assessed by NRS 0-10 (0, not satisfied at all; 10 very satisfied). |
Countries
China
Outcome results
None listed