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

NCT07336680 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: ON-UGIB25
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (1)

• patient cooperation

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

  from the beginning to the end of the endoscopic procedure

Secondary Outcomes (7)

• gagging intensity of patient

  from the beginning to the end of the endoscopic procedure

• visualization quality

  During the endoscopic procedure.

• Success rate of initial endoscopic hemostasis

  from the beginning to the end of the endoscopic procedure

• Proportion of patients needing repeat endoscopy within 72 hours

  from the time of the endoscopic procedure to 3 days after the endoscopic procedure.

• Recurrence of UGIB in 7 days

  from the day of the procedure to 7 days after it

Study Arms (2)

intravenous ondansetron

EXPERIMENTAL

Drug: intravenous ondansetron

control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

intravenous ondansetron

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.

control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Gastroenterology

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01