Esophagogastroduodenoscopy, Upper Gastrointestinal Bleeding (UGIB)
Conditions
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient cooperation | 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
| Measure | Time frame | Description |
|---|---|---|
| visualization quality | During the endoscopic procedure. | 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 | from the beginning to the end of the endoscopic procedure | the proportion of patients in each group who achieved hemostasis with a single endoscopic intervention |
| Proportion of patients needing repeat endoscopy within 72 hours | from the time of the endoscopic procedure to 3 days after the endoscopic procedure. | 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. |
| gagging intensity of patient | from the beginning to the end of the endoscopic procedure | gagging intensity of patient evaluated by the endoscopist, in numeric rating scale, 0 means none, 10 means extremely intense. |
| endoscopist workload | From the beginning to the end of the endoscopic procedure | 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. |
| adverse event | from the beginning of the intervention to 1 week after the endoscopic procedure. | Any adverse medical event occurring during the endoscopic procedure, regardless of its relationship to the study medication. |
| Recurrence of UGIB in 7 days | from the day of the procedure to 7 days after it | 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. |
Outcome results
None listed