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

Phase 4

Not yet recruiting

• Conditions: Esophagogastroduodensocopy (EGD) Procedure
• Interventions: Drug: Dyclonine hydrochloride mucilage; Drug: Oral ondansetron and dyclonine hydrochloride mucilage

• Registration Number: NCT06729307
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Study Start: 2025-01
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dyclonine hydrochloride mucilage only	Dyclonine hydrochloride mucilage	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.
oral ondansetron and dyclonine hydrochloride mucilage	Oral ondansetron and dyclonine hydrochloride mucilage	-

Primary Outcome Measures

Name	Time	Method
Overall discomfort of patients	from the start of the endoscopic process to the end of the endoscopic process	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

Secondary Outcome Measures

Name	Time	Method
Intensity of gagging evaluated by patients	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 patients after the endoscopic process is finished
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
Patient willingness to undergo unsedated EGD again	at the end of the endoscopic process	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).
Endoscopist satisfaction	from the start to the end of the endoscopic process	satisfaction of endoscopist in this process, assessed by NRS 0-10 (0, not satisfied at all; 10 very satisfied).