Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05641051

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

16.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Emptying Mechanically Ventilation Randomized Controlled Trial Metoclopramide	Drug: Metoclopramide Drug: Placebo	Phase 4

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

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 14, 2022

Anticipated Primary Completion Date :

May 14, 2023

Anticipated Study Completion Date :

May 14, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Assessment of the risk of aspiration [First 7 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

Incidence of ventilator associated pneumonia [First 7 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]
Hospital stay [From the start of enteral feeding till intensive care discharge through study completion, an average of 6months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Khadija Mohammed Elbaradei	Tanta	ElGharbiaa	Egypt	31527

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khadija Mohammed Elbaradei, Resident of Anesthesia, Surgical Intensive Care and Pain Medicine, Tanta University

ClinicalTrials.gov Identifier:

NCT05641051

Other Study ID Numbers:

35298/2/22

First Posted:

Dec 7, 2022

Last Update Posted:

Dec 7, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metoclopramide

Study Results

No Results Posted as of Dec 7, 2022