Effect of Ondansetron on Patient Tolerance, Efficacy and Endoscopist Workload in Unsedated Endoscopy for Upper Gastrointestinal Bleeding

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking Union Medical College Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • intravenous ondansetron

    Drug

    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.

  • Placebo

    Drug

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: intravenous ondansetronExperimental treatment 1 intervention
Group B: controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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.
3

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
4

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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