Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

Randomized Controlled Trial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05641051
• Other study ID #: 35298/2/22
• Status: Completed
• Phase: Phase 4
• Start date: December 14, 2022
• Est. completion date: June 16, 2023

Study information

• Verified date: June 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Emptying
• Randomized Controlled Trial

Intervention

Drug:
• Metoclopramide
Cases will receive 10 mg intravenous metoclopramide every 6 hours.
• Placebo
Cases will receive the same volume of IV placebo / 6 hours.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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