Trimebutine Maleate for Enhancing Gastric Visualization in Acute Upper Gastrointestinal Bleeding
Role of Trimebutine Maleate in Enhancing Endoscopic Gastric Visualization in Patients With Acute Upper Gastrointestinal Bleeding: A Double-Blind Randomized Controlled Trial
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- Phase 3
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Trimebutine Maleate Group
Participants in this group will receive an intravenous administration of 50 mg Trimebutine Maleate approximately 60 to 90 minutes prior to their scheduled urgent upper gastrointestinal endoscopy.
All patients will also receive standard medical treatment for acute upper gastrointestinal bleeding according to institutional protocols.
|
50 mg of Trimebutine Maleate administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.
|
|
Comparateur placebo: Placebo Group
Participants in this group will receive a matching placebo, consisting of an ampoule of saline, administered approximately 60 to 90 minutes prior to their scheduled urgent upper gastrointestinal endoscopy.
All patients will also receive standard medical treatment for acute upper gastrointestinal bleeding according to institutional protocols.
|
A matching placebo consisting of an ampoule of saline administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Gastric Visualization Score
Délai: 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.
|
60 to 90 minutes post-intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Identification Rate of Bleeding Source
Délai: 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.
|
60 to 90 minutes post-intervention
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies du système digestif
- Maladies gastro-intestinales
- Hémorragie
- Conditions pathologiques, signes et symptômes
- Hémorragie gastro-intestinale
- Produits chimiques organiques
- Hydrocarbures
- Hydrocarbures, cyclique
- Acides carboxyliques
- Acides hydroxy
- Hydrocarbures, aromatique
- Phénols
- Dérivés de benzène
- Acides, carbocyclique
- Benzoates
- Hydroxybenzoates
- Éthers phényles
- Éthers hydroxybenzoate
- Trimebutine
Autres numéros d'identification d'étude
- Trimebutine for UGIB Endoscopy
Informations sur les médicaments et les dispositifs, documents d'étude
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