Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297954
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2024-02-23
Brief Title:
Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding
Sponsor:
Universidad Autonoma de Nuevo Leon
Organization:
Universidad Autonoma de Nuevo Leon
Study Overview
Official Title:
Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None