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NCT Number: NCT07336680

Effect of Ondansetron on Patient Tolerance, Efficacy and Endoscopist Workload in Unsedated Endoscopy for Upper Gastrointestinal Bleeding

The goal of this clinical trial is to evaluate whether intravenous ondansetron can improve patient tolerance and reduce discomfort during unsedated emergency esophagogastroduodenoscopy (EGD). The main questions it aims to answer are:

* Does pre-procedural administration of ondansetron improve patient cooperation during emergency EGD? * Does it improve endoscopic field visibility and improve the success rate of initial endoscopic hemostasis？ * Does it reduce the operator's perceived workload or stress?

Researchers will compare patients who received intravenous ondansetron with patients who received placebo to see if ondansetron can reduce patient discomfort and improve patient cooperation, therefore improve the quality of the procedure.

Participants will receive either intravenous ondansetron and dyclonine hydrochloride mucilage or intravenous saline and dyclonine hydrochloride mucilage prior to the endoscopic procedure.

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Key information

Conditions

Esophagogastroduodenoscopy Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Upper Gastrointestinal Bleeding (UGIB)

Age range

18 year–65 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

  • Presence of suspected or confirmed upper gastrointestinal bleeding with an indication for emergent endoscopic intervention.
  • Capability to provide informed consent.

Exclusion criteria

  • Presence of any contraindication to upper gastrointestinal endoscopy.
  • Concurrent severe primary diseases of the respiratory, cardio-cerebrovascular, renal, central nervous, or hematologic systems.
  • Pregnancy.
  • Presence of neuropsychiatric disorders, including severe depression or severe anxiety.
  • Presence of a known history of cardiac arrhythmia.
  • Allergic to dyclonine hydrochloride or ondansetron.

Treatment and study plan

Intravenous ondansetron

Drug

Intravenous administration of 8 mg ondansetron 0.5-1h prior to endoscopic procedure and gurgle 10 ml dyclonine hydrochloride viscous solution (0.01 g/mL) 15 min prior to the endoscopic procedure.

Placebo

Drug

Intravenous administration of 8 ml saline 0.5-1h prior to endoscopic procedure and gurgle 10 ml dyclonine hydrochloride viscous solution (0.01 g/mL) 15 min prior to the endoscopic procedure.

Primary outcomes

  1. patient cooperation

    Time frame: from the beginning to the end of the endoscopic procedure

    evaluated by the endoscopist in numeric rating scale, 0 stands for not good at all, 10 stands for completely satisfied.

Secondary outcomes

  1. gagging intensity of patient

    Time frame: from the beginning to the end of the endoscopic procedure

    gagging intensity of patient evaluated by the endoscopist, in numeric rating scale, 0 means none, 10 means extremely intense.

  2. visualization quality

    Time frame: During the endoscopic procedure.

    Overall endoscopic visualization was evaluated at 4 locations including (i) gastric fundus, (ii) corpus, (iii) antrum, and (iv) duodenal bulb. The score is rated in the following criteria: 0, less than 25% of the surface was visible; 1, 25%-75% visible; and 2, more than 75% visible. The total score range was 0-8.

  3. Success rate of initial endoscopic hemostasis

    Time frame: from the beginning to the end of the endoscopic procedure

    the proportion of patients in each group who achieved hemostasis with a single endoscopic intervention

  4. Proportion of patients needing repeat endoscopy within 72 hours

    Time frame: from the time of the endoscopic procedure to 3 days after the endoscopic procedure.

    The proportion of patients who underwent a repeat upper gastrointestinal endoscopy for suspected rebleeding within 72 hours following the completion of the initial endoscopic procedure.

  5. Recurrence of UGIB in 7 days

    Time frame: from the day of the procedure to 7 days after it

    The proportion of patients in whom hemostasis was initially achieved by endoscopy, but who subsequently experienced recurrent bleeding within 7 days. Recurrent bleeding is defined by the occurrence of any of the following: hematemesis, melena, hematochezia, hemodynamic instability, or endoscopic confirmation of recurrent bleeding at the original site.

  6. endoscopist workload

    Time frame: From the beginning to the end of the endoscopic procedure

    Self-assessed by the endoscopist immediately after the procedure. It is measured across six dimensions-mental demand, physical demand, temporal demand, effort, performance, and frustration/anxiety-using a 0-100 mm visual analogue scale for each, where 0 represents "very low" and 100 represents "very high".

  7. adverse event

    Time frame: from the beginning of the intervention to 1 week after the endoscopic procedure.

    Any adverse medical event occurring during the endoscopic procedure, regardless of its relationship to the study medication.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 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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