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NCT Number: NCT06729307

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.

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Key information

Conditions

Esophagogastroduodensocopy (EGD) Procedure

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Overall discomfort of patients

    Time frame: 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 outcomes

  1. Intensity of gagging evaluated by patients

    Time frame: 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

  2. Intensity of patient gagging evaluated by endoscopist

    Time frame: 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

  3. Patient willingness to undergo unsedated EGD again

    Time frame: 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).

  4. Endoscopist satisfaction

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Min

CONTACT

[email protected]

+86 15313350760

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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