Metoclopramide in Upper Gastrointestinal Bleed

Study Overview
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Brief Summary
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The goal of this clinical trial is to test if metoclopramide can improve effectiveness of endoscopic intervention in upper gastrointestinal (GI) bleeds. The main questions the investigators hope to answer is Does metoclopramide lessen the need for repeat endoscopy, interventional radiology intervention or surgery in cases of upper GI bleed? Does metoclopramide improve visibility of the GI walls in cases of upper GI bleed?

Detailed Description
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The purpose of the study is to see if giving metoclopramide prior to an endoscopy in cases of upper GI bleed can decrease the need for repeat endoscopy due to poor visibility. Metoclopramide stimulates stomach and intestine activity. It is used to treat nausea, vomiting and slow gut movement. The investigators are testing if metoclopramide's effect on stimulating stomach activity can lead to more effective emptying of blood from the stomach and upper intestines in upper GI bleeding so physicians conducting endoscopies can easily see the stomach and intestinal wall and treat the source of bleeding.

Official Title
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Premedication With Metoclopramide in Upper Gastrointestinal Bleeds a Prospective Double Blinded Single Center Randomized Control Trial in a Small Community Hospital

Conditions
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Bleeds Gastric, Upper GI Bleeding, Bleed Ulcer, Hemorrhage Gastric, Hemorrhage; Ulcer

Intervention / Treatment
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* Drug: Metoclopramide 10mg
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above Admitted to ER or inpatient services at Javon Bea Hospital MercyHealth Riverside Present with upper GI bleeding defined as fresh and bright red hematemesis, coffee-ground hematemesis or melena Plan to undergo EGD within 24 hours since admission or since first symptoms Calculated Glasgow-Blatchford score ≥ 2 Exclusion Criteria: Failure to obtain informed consent Known allergy to metoclopramide Concurrent use of medications known to cause tardive dyskinesia (TD)/extrapyramidal symptoms/neuroleptic malignant syndrome History of TD or dystonic reaction to metoclopramide Pheochromocytoma, catecholamine-releasing paragangliomas Parkinson's Disease Epilepsy Pregnancy or lactation Previous gastrectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metoclopramide<br>Given 10 mg Metoclopramide prior to Endoscopy | Drug: Metoclopramide 10mg<br>* IV Metoclopramide<br>* Other names: Reglan;|
| Placebo Comparator: Placebo<br>Given saline flush prior to Endoscopy | Drug: Saline<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility | Will collect if repeat procedure occurred due to poor visibility (True/False) | During Current Hospitalization (up to day 14) | 
| Toronto Upper Gastroenterology Cleaning Score (TUGS) | Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility | During Endoscopy Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital stay (days) | Time in days between admission and discharge | During Current Hospitalization (up to day 14) | 
| Types of Adverse Neurological Side effects | Dystonia, Akathisia, Parkinsonism, Tardive Dyskinesia, Other | 3 month f/u | 
| Glasgow-Blatchford Bleeding Score | Score from 0-29 estimating risk of gastrointestinal bleed and need for inpatient admission, 0 indicating low risk, 29 indicating high risk of mortality | within 3 hours after admission | 
| Endoscopy Findings | Findings of endoscopy | During Endoscopy Procedure | 
| Endoscopy Start and End Times | Start and stop times of endoscopies | During Endoscopy Procedure | 
| Number of Blood Units Transfused in 24 hours | measure in units of blood transfused | within 24 hours after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGD, metoclopramide, prokinetic, Upper endoscopy, endoscopic gastroduodenoscopy, esophagogastroduodenoscopy