Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297954
• Other study ID #: GA22-00011
• Status: Recruiting
• Phase: Phase 3
• Start date: March 16, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Universidad Autonoma de Nuevo Leon
• Contact: José Luis Herrera Elizondo, Physician
• Phone: +528180182968
• Email: here_herrera_11[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 12 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.

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 12 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Drug:
• Metoclopramide
Patients will receive metoclopramide 20 mg IV in a single dose prior to randomization.
• Placebo
Patients will receive placebo 10 ml IV in a single dose prior to randomization.

Locations

Country	Name	City	State
Mexico	Hospital Universitario Dr. José Eleuterio González, UANL	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the usefulness of metoclopramide in improving endoscopic visualisation in patients with upper gastrointestinal bleeding.	Using 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.	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	To determine whether the use of metoclopramide avoids repeating the endoscopic procedure.	The need to repeat the endoscopic procedure will be evaluated in case clinical data of new bleeding from the digestive tract, evidenced by melena or hematemesis is found.	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.
Secondary	To determine whether the use of metoclopramide shortens the length of hospital stay.	The days of hospital stay will be counted and comparing both arms.	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.