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

NCT07336680 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-13

No results posted yet for this study

Summary

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.

Conditions

  • Esophagogastroduodenoscopy
  • Upper Gastrointestinal Bleeding (UGIB)

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-05-31
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07336680 on ClinicalTrials.gov