Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Metoclopramide for Acute Upper GI Bleeding

NCT04771481

Acute Upper Gastrointestinal Bleeding Effect of Drug

COMPLETED PHASE4

Metoclopramide for Gastric Visualization in Active Upper GI Bleeding

NCT06167837

Upper GI Bleeding

RECRUITING PHASE4

Metoclopramide in Upper Gastrointestinal Bleed

NCT05746377

Upper GI Bleeding Bleeds Gastric Bleed Ulcer +2 more

UNKNOWN PHASE4

Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy

NCT01631994

Gastric Transit Time

TERMINATED NA

Metoclopramide Versus Placebo for GJ Placement

NCT03331965

Radiation Exposure Enteral Nutrition

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Gastrointestinal Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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. The sequence of treatment (metoclopramide) and placebo in which they will be distributed to patients will be determined using randomization software. A folio number will be assigned and depending on the sequence the treatment or placebo will be administered. 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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

As it is double-blind, both physician and patient will not know the treatment they are receiving and it will only be revealed later at the end of the protocol. Following the previous folios, both the treatment and the placebo will be distributed in boxes by default by the research staff, delivering them to the personnel who will apply the drug or placebo, indicating the doses and frequencies of these when administered.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metoclopramide

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

Group Type EXPERIMENTAL

Metoclopramide

Intervention Type DRUG

Patients will receive metoclopramide 20 mg IV in a single dose prior to randomization.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will receive placebo 10 ml IV in a single dose prior to randomization.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metoclopramide

Patients will receive metoclopramide 20 mg IV in a single dose prior to randomization.

Intervention Type DRUG

Placebo

Patients will receive placebo 10 ml IV in a single dose prior to randomization.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.