Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.

Texas Tech University Health Sciences Center, El Paso

Status: Terminated

Conditions: Upper Gastrointestinal Bleeding

Treatments: Drug: Metoclopromide; Drug: Erythromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02017379

E13018

Details and patient eligibility

About

This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs (Drugs which are known to speed up the emptying of the stomach or in other words to move the blood out of the stomach faster) given before endoscopy to patients with upper Gastrointestinal bleeding compared to patients who will not receive either of these medications before their endoscopy.

Full description

To compare the efficacy of pre-endoscopic interventions namely erythromycin, metoclopromide vs control in improving the outcomes of endoscopy in ICU patients admitted upper GI bleeding.

Specific aims:

1. Wither erythromycin, metoclopromide vs control can enable visualization of the entire gastric mucosa .
2. Wither erythromycin, metoclopromide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al

Enrollment: 4 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (18-80)
• who are admitted to the ICU for hematemesis, or coffee ground emesis

Exclusion criteria

1. Patients younger than 18 yrs old or older than 80 yrs

2. Patients who refuse to consent to be in our study

3. Pregnant patients

4. Prior use of prokinetics in the last 48 hours

5. History of cardiac arrhythmia

6. Allergy to erythromycin or metoclopromide

7. Patients with QT prolongation (query 7)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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4 participants in 3 patient groups

Erythromycin

Experimental group

Description:

Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure

Treatment:

Drug: Erythromycin

Metoclopromide

Experimental group

Description:

Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy

Treatment:

Drug: Metoclopromide

Control

No Intervention group

Description:

no medications will be given prior to endoscopy