Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

NCT05641051 | Completed Phase 4

• 1 other identifier: 35298/2/22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Emptying; Mechanically Ventilation; Randomized Controlled Trial; Metoclopramide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Metoclopramide group

EXPERIMENTAL

Patients will receive 10 mg intravenous metoclopramide / 6 hours.

Drug: Metoclopramide

Control group

PLACEBO COMPARATOR

Patients will receive the same volume of intravenous placebo / 6 hours.

Drug: Placebo

Interventions

Metoclopramide DRUG

Cases will receive 10 mg intravenous metoclopramide every 6 hours.

Metoclopramide group

Placebo DRUG

Cases will receive the same volume of IV placebo / 6 hours.

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients' age 20 - 60 years.
• Either gender.
• Mechanically ventilated head trauma patients.
• Patients receiving enteral feeding via nasogastric tube.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

Location

MeSH Terms

Interventions

Metoclopramide

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 7, 2022
• Study Start: December 14, 2022
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)