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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 4

Conditions: Esophagogastroduodensocopy (EGD) Procedure

Treatments: Drug: Oral ondansetron and dyclonine hydrochloride mucilage; Drug: Dyclonine hydrochloride mucilage

Study type: Interventional

Funder types: Other

Identifiers

NCT06729307

2024-OUEGD

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

oral ondansetron and dyclonine hydrochloride mucilage

Experimental group

Treatment:

Drug: Oral ondansetron and dyclonine hydrochloride mucilage

dyclonine hydrochloride mucilage only

Other group

Description:

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.

Treatment:

Drug: Dyclonine hydrochloride mucilage