About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of suspected or confirmed upper gastrointestinal bleeding with an indication for emergent endoscopic intervention.
Capability to provide informed consent.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
intravenous ondansetron
DrugIntravenous 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.
Placebo
DrugIntravenous 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.
Treatment groups
Trial outcomes
Primary outcomes
patient cooperation
evaluated by the endoscopist in numeric rating scale, 0 stands for not good at all, 10 stands for completely satisfied.
Secondary outcomes
gagging intensity of patient
gagging intensity of patient evaluated by the endoscopist, in numeric rating scale, 0 means none, 10 means extremely intense.
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.
Success rate of initial endoscopic hemostasis
the proportion of patients in each group who achieved hemostasis with a single endoscopic intervention
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: