Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

Phase 4

Completed

• Conditions: Metoclopramide; Randomized Controlled Trial; Gastric Emptying; Mechanically Ventilation
• Interventions: Drug: Placebo; Drug: Metoclopramide

• Registration Number: NCT05641051
• Lead Sponsor: Tanta University

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 Timeline

• Study First Submitted: 2022-11-27
• Study First Submitted QC: 2022-12-04
• Study First Posted: 2022-12-07
• Study Start: 2022-12-14
• Status Verified: 2023-06
• Primary Completion: 2023-06-16
• Study Completion: 2023-06-16
• Last Update Submitted: 2023-06-17
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	Patients will receive the same volume of intravenous placebo / 6 hours.
Metoclopramide group	Metoclopramide	Patients will receive 10 mg intravenous metoclopramide / 6 hours.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, ElGharbiaa, Egypt