Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

Study Overview
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Brief Summary
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The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .

Detailed Description
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More than 50% of patients in ICU have gastric dysmotility, which leads to slow gastric emptying(GE) and high gastric residual volume (GRV) and is associated with increased mortality in these patients

Official Title
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Effects of Metoclopramide Administration on Gastric Emptying in Mechanically Ventilated Critically Ill Patients : A Prospective Randomized Controlled Trial

Conditions
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Gastric Emptying, Mechanically Ventilation, Randomized Controlled Trial, Metoclopramide

Intervention / Treatment
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* Drug: Metoclopramide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients' age 20 - 60 years. Either gender. Mechanically ventilated head trauma patients. Patients receiving enteral feeding via nasogastric tube. Exclusion Criteria: Patients with contraindications to enteral feeding. Patients with extrapyramidal manifestations. Patients with known allergy to metoclopramide. Patients with seizures. Patients with renal or hepatic diseases.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metoclopramide group<br>Patients will receive 10 mg intravenous metoclopramide / 6 hours. | Drug: Metoclopramide<br>* Cases will receive 10 mg intravenous metoclopramide every 6 hours.<br>|
| Placebo Comparator: Control group<br>Patients will receive the same volume of intravenous placebo / 6 hours. | Drug: Placebo<br>* Cases will receive the same volume of IV placebo / 6 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the risk of aspiration | Aspiration risk will be categorized using the system proposed by Ven de Putte and Perlas. As: patients with empty antrum and gastric residual volume < 1.5 mL/kg: low risk. patients with solid contents or gastric residual volume > 1.5 mL/kg: high risk. | 8 hours interval during first 5 days of enteral feeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ventilator associated pneumonia | Pneumonia will be defined according to the ATS/IDSA clinical criteria and will be diagnosed if a new or progressive radiographic infiltrate is present and at least two of the three following clinical features are also present: (1) fever higher than 38°C, (2) leukocytosis or leucopenia and (3) purulent secretions. No microbiological confirmation is required for diagnosis of pneumonia. Infectious Diseases. Society of America (IDSA) and the American Thoracic. Society (ATS) | 8 hours interval during first 5 days of enteral feeding | 
| Time of weaning from mechanical ventilation | Time of weaning from mechanical ventilation From the start of enteral feeding | From the start of enteral feeding till intensive care discharge through study completion, an average of 6months | 
| Hospital stay | Hospital stay including intensive care and ward. | From the start of enteral feeding till intensive care discharge through study completion, an average of 6months |