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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral ondansetron and dyclonine hydrochloride mucilage | Experimental |
| |
| dyclonine hydrochloride mucilage only | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ondansetron and dyclonine hydrochloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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). | from the previous endoscopy to 30 minutes after the current endoscopy is finished |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient gagging intensity | 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). | from the previous endoscopic examination to 30 minutes after the current examination is finished. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| dyclonine hydrochloride only | Drug | 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. |
|
| 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). | 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 | 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). | from the start to the end of the endoscopic process |
| ID | Term |
|---|---|
| D017294 | Ondansetron |
| C100063 | dyclonine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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