Premedication With Metoclopramide in Upper Gastrointestinal Bleeds a Prospective Double Blinded Single Center Randomized Control Trial in a Small Community Hospital
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Mercy Health System
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
Randomization protocol instituted by pharmacy, patient and endoscopist blinded to treatment assignment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Pregnancy or lactation
- •Previous gastrectomy
Arms & Interventions
Metoclopramide
Given 10 mg Metoclopramide prior to Endoscopy
Intervention: Metoclopramide 10mg (Drug)
Placebo
Given saline flush prior to Endoscopy
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility
Time Frame: During Current Hospitalization (up to day 14)
Will collect if repeat procedure occurred due to poor visibility (True/False)
Toronto Upper Gastroenterology Cleaning Score (TUGS)
Time Frame: During Endoscopy Procedure
Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility
Secondary Outcomes
- Endoscopy Findings(During Endoscopy Procedure)
- Length of Hospital stay (days)(During Current Hospitalization (up to day 14))
- Types of Adverse Neurological Side effects(3 month f/u)
- Glasgow-Blatchford Bleeding Score(within 3 hours after admission)
- Number of Blood Units Transfused in 24 hours(within 24 hours after admission)
- Endoscopy Start and End Times(During Endoscopy Procedure)
Investigators
Mudassar Sandozi
Principal Investigator
Mercy Health System