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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 3
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador de placebos: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total Gastric Visualization Score
Periodo de tiempo: 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.
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60 to 90 minutes post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Identification Rate of Bleeding Source
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Hemorragia
- Condiciones Patológicas, Signos y Síntomas
- Hemorragia Gastrointestinal
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Ácidos carboxílicos
- Ácidos hidroxi
- Hidrocarburos, aromáticos
- Fenoles
- Derivados de benceno
- Ácidos, carbocíclicos
- Benzoates
- Hidroxibenzoates
- Fenilo éter
- Éteres hidroxibenzoato
- Tritimebutino
Otros números de identificación del estudio
- Trimebutine for UGIB Endoscopy
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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