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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
80
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 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.
patient cooperation
evaluated by the endoscopist in numeric rating scale, 0 stands for not good at all, 10 stands for completely satisfied.
Time frame: from the beginning to the end of the endoscopic procedure
gagging intensity of patient
gagging intensity of patient evaluated by the endoscopist, in numeric rating scale, 0 means none, 10 means extremely intense.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: from the day of the procedure to 7 days after it
endoscopist workload
Self-assessed by the endoscopist immediately after the procedure. It is measured across six dimensions-mental demand, physical demand, temporal demand, effort, performance, and frustration/anxiety-using a 0-100 mm visual analogue scale for each, where 0 represents "very low" and 100 represents "very high".
Time frame: From the beginning to the end of the endoscopic procedure
adverse event
Any adverse medical event occurring during the endoscopic procedure, regardless of its relationship to the study medication.
Time frame: from the beginning of the intervention to 1 week after the endoscopic procedure.
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