Effects of Metoclopramide Administration on Gastric Emptying in Mechanically Ventilated Critically Ill Patients : A Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Assessment of the risk of aspiration
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, 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 Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Metoclopramide group
Patients will receive 10 mg intravenous metoclopramide / 6 hours.
Intervention: Metoclopramide (Drug)
Control group
Patients will receive the same volume of intravenous placebo / 6 hours.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Assessment of the risk of aspiration
Time Frame: 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 Outcomes
- Incidence of ventilator associated pneumonia(8 hours interval during first 5 days of enteral feeding)
- Time of weaning from mechanical ventilation(From the start of enteral feeding till intensive care discharge through study completion, an average of 6months)
- Hospital stay(From the start of enteral feeding till intensive care discharge through study completion, an average of 6months)
Investigators
Khadija Mohammed Elbaradei
Resident of Anesthesia, Surgical Intensive Care and Pain Medicine
Tanta University