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

NCT06729307 | Not Yet Recruiting Phase 4

• 1 other identifier: 2024-OUEGD
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intensity of gagging evaluated by patients

  from the start of the endoscopic process to the end of the endoscopic process

• Intensity of patient gagging evaluated by endoscopist

  from the start of the endoscopic process to the end of the endoscopic process

• Patient willingness to undergo unsedated EGD again

  at the end of the endoscopic process

• Endoscopist satisfaction

  from the start to the end of the endoscopic process

Study Arms (2)

oral ondansetron and dyclonine hydrochloride mucilage

EXPERIMENTAL

Drug: Oral ondansetron and dyclonine hydrochloride mucilage

dyclonine hydrochloride mucilage only

OTHER

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

Interventions

Oral ondansetron and dyclonine hydrochloride mucilage 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.

oral ondansetron and dyclonine hydrochloride mucilage

Dyclonine hydrochloride mucilage 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.

dyclonine hydrochloride mucilage only

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Min

CONTACT

+86 15313350760; minyy19@student.pumc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share