Gastric Emptying, Mechanically Ventilation, Metoclopramide, Randomized Controlled Trial
Conditions
Brief summary
The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .
Detailed description
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
Interventions
DRUGMetoclopramide
Cases will receive 10 mg intravenous metoclopramide every 6 hours.
DRUGPlacebo
Cases will receive the same volume of IV placebo / 6 hours.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The drugs will be prepared by a dedicated anesthesiologist who is aware of the allocated group and will have no subsequent role in the study.
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the risk of aspiration | 8 hours interval during first 5 days of enteral feeding | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ventilator associated pneumonia | 8 hours interval during first 5 days of enteral feeding | 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 of weaning from mechanical ventilation | From the start of enteral feeding till intensive care discharge through study completion, an average of 6months | Time of weaning from mechanical ventilation From the start of enteral feeding |
| Hospital stay | From the start of enteral feeding till intensive care discharge through study completion, an average of 6months | Hospital stay including intensive care and ward. |
Countries
Egypt
Outcome results
None listed