Oral Ondansetron to Improve Patient Experience of Unsedated Esophagogastroduodenoscopy Pilot Study

NCT ID: NCT07264738

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-12-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

oral ondansetron and dyclonine hydrochloride mucilage

Group Type: EXPERIMENTAL

ondansetron and dyclonine hydrochloride

Intervention Type: 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.

dyclonine hydrochloride mucilage only

Group Type: OTHER

dyclonine hydrochloride only

Intervention Type: 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.

Interventions

ondansetron 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.

Intervention Type: DRUG

dyclonine 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

DONG WU

Chief physician of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ON-COMFORT25

Identifier Type: -

Identifier Source: org_study_id