Oral Ondansetron to Improve Patient Experience of Unsedated Esophagogastroduodenoscopy Pilot Study

NCT07264738 | Active Not Recruiting Phase 4

• 1 other identifier: ON-COMFORT25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagogastroduodensocopy (EGD) Procedure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in patient gagging intensity

  from the previous endoscopic examination to 30 minutes after the current examination is finished.

• Patient willingness to undergo unsedated EGD again

  from start of endoscopy to 30 minutes after the examination is finished

• Intensity of patient gagging evaluated by endoscopist

  from the start of the endoscopic process to the end of the endoscopic process

• Endoscopist satisfaction for patient cooperation

  from the start to the end of the endoscopic process

Study Arms (2)

oral ondansetron and dyclonine hydrochloride mucilage

EXPERIMENTAL

Drug: ondansetron and dyclonine hydrochloride

dyclonine hydrochloride mucilage only

OTHER

Drug: dyclonine hydrochloride only

Interventions

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.

oral ondansetron and dyclonine hydrochloride mucilage

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.

dyclonine hydrochloride mucilage only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled for follow-up EGD at PUMCH
• Signing a written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Interventions

Ondansetron; dyclonine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Gastroenterology

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: July 1, 2025
• Primary Completion: September 28, 2025
• Study Completion (Estimated): June 10, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)