Clinical trial NCT06297954: Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding
Official title: Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Upper Gastrointestinal Bleeding
Keywords: Metoclopramide
Endoscopy
Hematemesis
Melena
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the usefulness of metoclopramide in improving endoscopic visualisation in patients with upper gastrointestinal bleeding.
timeFrame: From admission to discharge for up to 5 days, during this time their clinical condition will be evaluated, through a general physical examination, taking vital signs and questioning them about possible side effects associated with metoclopramide
Secondary outcomes:
measure: To determine whether the use of metoclopramide avoids repeating the endoscopic procedure.
timeFrame: From admission to discharge for up to 5 days, during this time it will be evaluated the need for new endoscopy in case clinical data of new bleeding from the digestive tract evidenced by melena or hematemesis.
measure: To determine whether the use of metoclopramide shortens the length of hospital stay.
timeFrame: From admission to discharge for up to 30 days, during this time their clinical condition will be evaluated, through a general physical examination, taking vital signs and questioning them about possible side effects associated with metoclopramide.
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González, UANL
state: Nuevo León
Study officials:
affiliation: Hospital Universitario Dr. José Eleuterio González, UANL
name: José Luis Herrera Elizondo, Physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: Estes DJ, Berera S, Deshpande AR, Sussman DA. Re-Visiting Metoclopramide to Optimize Visualization with Gastrointestinal Bleeding - Mobilizing Existing Data. Clin Endosc. 2019 Sep;52(5):516-517. doi: 10.5946/ce.2019.046. Epub 2019 Jul 16. No abstract available.