Effect of Ondansetron on Patient Tolerance, Efficacy and Endoscopist Workload in Unsedated Endoscopy for Upper Gastrointestinal Bleeding
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- patient cooperation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
control
Intervention: Placebo (Drug)
intravenous ondansetron
Intervention: intravenous ondansetron (Drug)
Outcomes
Primary Outcomes
patient cooperation
Time Frame: from the beginning to the end of the endoscopic procedure
evaluated by the endoscopist in numeric rating scale, 0 stands for not good at all, 10 stands for completely satisfied.
Secondary Outcomes
- endoscopist workload(From the beginning to the end of the endoscopic procedure)
- 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)
- adverse event(from the beginning of the intervention to 1 week after 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)
Investigators
DONG WU
Chief physician of Gastroenterology
Peking Union Medical College Hospital