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

NCT ID: NCT06729307

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-01-31

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.

Conditions

Esophagogastroduodensocopy (EGD) Procedure

Study Design

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

Study Groups

oral ondansetron and dyclonine hydrochloride mucilage

Group Type: EXPERIMENTAL

Oral ondansetron and dyclonine hydrochloride mucilage

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

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.

Group Type: OTHER

Dyclonine hydrochloride mucilage

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

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Min

Role: CONTACT

Phone: +86 15313350760

Email: minyy19@student.pumc.edu.cn

Other Identifiers

2024-OUEGD

Identifier Type: -

Identifier Source: org_study_id