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NCT Number: NCT07264738

Oral Ondansetron to Improve Patient Experience of Unsedated Esophagogastroduodenoscopy Pilot Study

The goal of this interventional pilot study is to explore the feasibility of administering ondansetron prior to esophagogastroduodenoscopy (EGD), and preliminarily test if it can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are:

Is adding oral ondansetron to pre-medication regimen of unsedated EGD safe, easy to conduct, and well-accepted by patients? May taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? May 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 answer the questions above.

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Esophagogastroduodensocopy (EGD) Procedure

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients scheduled for follow-up EGD at PUMCH
  • Signing a written informed consent.

Exclusion criteria

  • Contraindications for esophagogastroduodenoscopy.
  • History of upper gastrointestinal tract surgery.
  • With conditions indicated for emergency EGD, such as upper gastrointestinal bleeding
  • 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

ondansetron and dyclonine hydrochloride

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 only

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. Change in overall discomfort

    Time frame: from the previous endoscopy to 30 minutes after the current endoscopy is finished

    All 20 patients were follow-up patients who had unsedated EGD before. They assessed their degree of overall discomfort during the curent examination and the previous examination, both in numeric rating scale (NRS, on a scale from 0 to 10, 0 means no discomfort, 10 means extremely uncomfortable). Change in overall discomfort is the value of the difference between the previous and current NRS (previous-current).

Secondary outcomes

  1. Change in patient gagging intensity

    Time frame: from the previous endoscopic examination to 30 minutes after the current examination is finished.

    Patients assessed their gagging intensity during the curent examination and the previous examination, both in NRS 0-10, 0 means no gagging, 10 means extremely intense gagging. Change in overall discomfort is the value of the difference between the previous and current NRS (previous-current).

  2. Patient willingness to undergo unsedated EGD again

    Time frame: from start of endoscopy to 30 minutes after the examination is finished

    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).

  3. 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

  4. Endoscopist satisfaction for patient cooperation

    Time frame: from the start to the end of the endoscopic process

    satisfaction of endoscopist for patient cooperation in this process, assessed by NRS 0-10 (0, not satisfied at all; 10 very satisfied).

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Oral Ondansetron to Improve Patient Experience of Unsedated Esophagogastroduodenoscopy: A Pilot Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
May 1, 2026

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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