Effect of Ondansetron on Patient Tolerance, Efficacy and Endoscopist Workload in Unsedated Endoscopy for Upper Gastrointestinal Bleeding
Starting soon · Phase 4 · Has a placebo group
Conditions studied: Esophagogastroduodenoscopy, Upper Gastrointestinal Bleeding (UGIB)
In brief
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.
Key facts
- Study ID
- NCT07336680
- Run by
- Peking Union Medical College Hospital
- People needed
- 80
- Starts
- 2026-01-01
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2026-01-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Presence of suspected or confirmed upper gastrointestinal bleeding with an indication for emergent endoscopic intervention.
- Capability to provide informed consent.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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