Menu
Not yet recruiting NCT07336680

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

Phase IV Interventional Esophagogastroduodenoscopy Upper Gastrointestinal Bleeding (UGIB)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intravenous ondansetron, Placebo.
Who it may be relevant to
Registry conditions: Esophagogastroduodenoscopy, Upper Gastrointestinal Bleeding (UGIB). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug intravenous ondansetron
    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.
  • Drug Placebo
    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 outcome measures

  • patient cooperation [Time frame: from the beginning to the end of the endoscopic procedure]
Secondary outcome measures (7)
  • gagging intensity of patient [Time frame: from the beginning to the end of the endoscopic procedure]
  • visualization quality [Time frame: During the endoscopic procedure.]
  • Success rate of initial endoscopic hemostasis [Time frame: from the beginning to the end of the endoscopic procedure]
  • 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.]
  • Recurrence of UGIB in 7 days [Time frame: from the day of the procedure to 7 days after it]
  • endoscopist workload [Time frame: From the beginning to the end of the endoscopic procedure]
  • adverse event [Time frame: from the beginning of the intervention to 1 week after the endoscopic procedure.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07336680 · ON-UGIB25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗