Acute Upper Gastrointestinal Bleeding, Gastrointestinal Hemorrhage, Upper Gastrointestinal Bleeding
Conditions
Keywords
Trimebutine Maleate, Trimebutine, Gastric Visualization, Endoscopy, Esophagogastroduodenoscopy
Brief summary
Acute upper gastrointestinal bleeding is a medical emergency that requires an urgent upper endoscopy to locate and treat the source of the bleeding. Often, retained blood and clots in the stomach make it difficult for the endoscopist to clearly see the stomach's anatomical structures. This study aims to evaluate if administering a medication called Trimebutine Maleate before the endoscopy can help empty the stomach of residual blood and improve the doctor's view. Trimebutine Maleate is a widely prescribed medication that regulates gastrointestinal movement and has a favorable safety profile compared to other medications used for this purpose. Researchers will include 100 adult patients experiencing acute upper gastrointestinal bleeding who are scheduled for an urgent endoscopy within 24 hours of presentation. Participants will be randomly assigned to receive either 50 mg of intravenous Trimebutine Maleate or a matching placebo (saline solution) 60 to 90 minutes before their procedure. All participants will continue to receive standard medical treatment for their bleeding according to normal hospital protocols. The primary goal of the study is to compare the clarity of the stomach view between the two groups using a standardized Gastric Visualization Score. The research team will also measure how often the exact bleeding source is successfully identified, the total duration of the procedure, and whether patients require a repeat endoscopy or a stomach washout (gastric lavage).
Interventions
50 mg of Trimebutine Maleate administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.
OTHERPlacebo
A matching placebo consisting of an ampoule of saline administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Clinical evidence of AUGIB: Hematemesis, coffee-ground vomiting or melena. * Planned urgent upper gastrointestinal endoscopy within 24 hours.
Exclusion criteria
* Known gastric outlet obstruction. * Previous gastric surgery. * Pregnancy or lactation. * Allergy to Trimebutine Maleate. * Chronic use of prokinetic medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Gastric Visualization Score | 60 to 90 minutes post-intervention | Gastric visualization will be assessed by the endoscopist across five anatomical areas: the fundus, upper body, lower body, antrum, and duodenum. Each area is evaluated using a 4-point scale: 0 (large amount of blood/clots obscuring vision), 1 (moderate blood requiring suction), 2 (small amount of blood with adequate visualization), and 3 (excellent visualization). The scores from all five areas are summed to create a Total Gastric Visualization Score ranging from 0 to 15, with higher scores indicating better visualization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification Rate of Bleeding Source | 60 to 90 minutes post-intervention | Percentage of participants in whom the specific anatomical source of upper gastrointestinal bleeding is successfully identified during the endoscopy procedure. |
Outcome results
None listed