Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

Tanta University80 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Gastric Emptying Mechanically Ventilation Randomized Controlled Trial Metoclopramide

Interventions

MetoclopramideDRUG

Cases will receive 10 mg intravenous metoclopramide every 6 hours.

PlaceboDRUG

Cases will receive the same volume of IV placebo / 6 hours.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients' age 20 - 60 years. 2. Either gender. 3. Mechanically ventilated head trauma patients. 4. Patients receiving enteral feeding via nasogastric tube. Exclusion Criteria: 1. Patients with contraindications to enteral feeding. 2. Patients with extrapyramidal manifestations. 3. Patients with known allergy to metoclopramide. 4. Patients with seizures. 5. Patients with renal or hepatic diseases.

Locations (1)

Tanta University Hospitals

Tanta, ElGharbiaa, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 8 hours interval during first 5 days of enteral feeding

Secondary Outcomes

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)

Time frame: 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

Time frame: 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.

Time frame: From the start of enteral feeding till intensive care discharge through study completion, an average of 6months

Data from ClinicalTrials.gov

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