Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

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

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

Study Overview

• Status: Completed
• Conditions: Randomized Controlled Trial; Gastric Emptying; Mechanically Ventilation; Metoclopramide
• Intervention / Treatment: Drug: Metoclopramide; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • ElGharbiaa
    • Tanta, ElGharbiaa, Egypt, 31527
      • Tanta University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metoclopramide group; Patients will receive 10 mg intravenous metoclopramide / 6 hours.	Drug: Metoclopramide; Cases will receive 10 mg intravenous metoclopramide every 6 hours.
Placebo Comparator: Control group; Patients will receive the same volume of intravenous placebo / 6 hours.	Drug: Placebo; Cases will receive the same volume of IV placebo / 6 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: November 27, 2022
• First Submitted That Met QC Criteria: December 4, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Metoclopramide
• Other Study ID Numbers: 35298/2/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available upon reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No