EsophagogastroduodenoscopyPhase 4NCT07336680
Effect of Ondansetron on Patient Tolerance, Efficacy and Endoscopist Workload in Unsedated Endoscopy for Upper Gastrointestinal Bleeding
A Phase 4 study testing intravenous ondansetron in people with Esophagogastroduodenoscopy and Upper Gastrointestinal Bleeding (UGIB), run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esophagogastroduodenoscopy, Upper Gastrointestinal Bleeding (UGIB)
- What is being tested?
- intravenous ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2026to 15 Aug 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of suspected or confirmed upper gastrointestinal bleeding with an indication for emergent endoscopic intervention.
- Capability to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
About this study
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?
Read more
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.
- Being tested
- intravenous ondansetron, Placebo
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous ondansetronDrug
Intravenous administration of 8 mg ondansetron ( in a 4 mL solution) 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.
PlaceboDrug
Intravenous administration of 4 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.
| Study group | Role | What they receive |
|---|---|---|
| intravenous ondansetron | Experimental | Not described Receives: Drug: intravenous ondansetron |
| control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient cooperation
evaluated by the endoscopist in numeric rating scale, 0 stands for not good at all, 10 stands for completely satisfied.
Measured: from the beginning to the end of the endoscopic procedure
Secondary outcomes (9)
gagging intensity of patient
gagging intensity of patient evaluated by the endoscopist, in numeric rating scale, 0 means none, 10 means extremely intense.
Measured: from the beginning to the end of the endoscopic procedure
endoscopist workload
Self-assessed by the endoscopist immediately after the procedure. It is measured via the NASA task load index (NASA-TLX) across six dimensions-mental demand, physical demand, temporal demand, effort, performance, and frustration. A 0-100 mm visual analogue scale is for each dimension, where 0 represents "very low" and 100 represents "very high".
Measured: From the beginning to the end of the endoscopic procedure
visualization quality
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.
Measured: During the endoscopic procedure.
Success rate of initial endoscopic hemostasis
the proportion of patients in each group who achieved hemostasis with a single endoscopic intervention
Measured: from the beginning to the end of the endoscopic procedure
Proportion of patients needing repeat endoscopy within 72 hours
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.
Measured: from the time of the endoscopic procedure to 3 days after the endoscopic procedure.
Recurrence of UGIB in 7 days
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.
Measured: from the day of the procedure to 7 days after it
Recurrence of UGIB in 30 days
The proportion of patients in whom hemostasis was initially achieved by endoscopy, but who subsequently experienced recurrent bleeding within 30 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.
Measured: From the day of the procedure to 30 days after it
adverse event
Any adverse medical event occurring during the endoscopic procedure, regardless of its relationship to the study medication.
Measured: from the beginning of the intervention to the end of the endoscopic procedure
Procedure duration
Measured: From the start to the end of the endoscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start16 Feb 2026
- Primary completion15 Jul 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagogastroduodenoscopyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DONG WU, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336680
- Sponsor's protocol ID
- ON-UGIB25
- Status last verified
- Sep 2026
- First submitted
- 2 Jan 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No