Hospital Universitario Dr. José Eleuterio González, UANL
Monterrey, Nuevo León, 64460, Mexico
NCT Number: NCT06297954
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.
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All sexes
Interventional
Phase 3
Monterrey, Nuevo León, 64460, Mexico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive metoclopramide 20 mg IV in a single dose prior to randomization.
Patients will receive placebo 10 ml IV in a single dose prior to randomization.
Time frame: 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
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.
Time frame: 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.
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.
Time frame: 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.
The days of hospital stay will be counted and comparing both arms.
Universidad Autonoma de Nuevo Leon
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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