Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophagogastroduodensocopy (EGD) Procedure
• Intervention / Treatment: Drug: Oral ondansetron and dyclonine hydrochloride mucilage; Drug: Dyclonine hydrochloride mucilage

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Min; Phone Number: +86 15313350760; Email: minyy19@student.pumc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral ondansetron and dyclonine hydrochloride mucilage	Drug: Oral 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.
Other: dyclonine hydrochloride mucilage only; Patients are treated with only topical pharyngeal anesthesia (dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process), with no antiemetic drug or placebo.	Drug: Dyclonine hydrochloride mucilage; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall discomfort of patients	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	from the start of the endoscopic process to the end of the endoscopic process

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of gagging evaluated by patients	measured by NRS 0-10 (0 none, 10 extremely strong), in a questionnaire given to patients after the endoscopic process is finished	from the start of the endoscopic process to the end of the endoscopic process
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
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).	at the end of the endoscopic process
Endoscopist satisfaction	satisfaction of endoscopist 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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Dermatologic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Antipruritics; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Ondansetron; Dyclonine
• Other Study ID Numbers: 2024-OUEGD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No