Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding

Universidad Autonoma de Nuevo Leon

Status and phase: Completed; Phase 3

Conditions: Upper Gastrointestinal Bleeding

Treatments: Drug: Metoclopramide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06297954

GA22-00011

Details and patient eligibility

About

A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 24 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale.

Full description

A prospective, longitudinal, randomized, double-blind study will be carried out in which all patients who come to the University Hospital "Dr. José Eleuterio González" with upper gastrointestinal tract bleeding, defined in our study as hematemesis or melena, including patients with this condition in the 24 hours prior to admission. Patients will be randomized to receive metoclopramide 20 mg IV or placebo, this randomization will be performed by means of a computer sequence to receive each of the treatment sequences. Subsequently, the upper endoscopy will be performed in the following 120 minutes, and the endoscopic visualization will be evaluated by the physician performing the procedure by means of the modified Avgerinos scale; which gives a score of 0-2 according to the percentage of mucosal vision; 0= <25% visible surface, 1= 25%-75% visible surface and 2= >75% visible surface, evaluating fundus, body, antrum and bulb, a score ≥ 6 will be considered a clean stomach and a score ≤ 5 will be considered full stomach. The diagnosis of origin of the upper gastrointestinal tract bleeding will be determined by the physician in charge of performing the endoscopy. All cases will be filmed and another physician will review the cases and validate the Avgerinos score, as well as the final diagnosis reported.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized patients ≥18 years of age with variceal and non-variceal upper gastrointestinal tract bleeding (hematemesis and/or melena).
• ≤12 hours of bleeding evolution.
• Hemodynamic stability at the time of upper endoscopy.

Exclusion criteria

• Patients <18 years old.
• Pregnant patients.
• Metoclopramide allergy.
• Refusal to be part of the study protocol.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Metoclopramide

Experimental group

Description:

Patients will be randomized to receive metoclopramide 20 mg IV single dose.

Treatment:

Drug: Metoclopramide

Placebo

Placebo Comparator group

Description:

Patients will be randomized to receive placebo 10 ml IV single dose.

Treatment:

Drug: Placebo