Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

NCT ID: NCT05641051

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-14

Study Completion Date

2023-06-16

Brief Summary

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

Detailed Description

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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

Conditions

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Gastric Emptying Mechanically Ventilation Randomized Controlled Trial Metoclopramide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Metoclopramide group

Patients will receive 10 mg intravenous metoclopramide / 6 hours.

Group Type EXPERIMENTAL

Metoclopramide

Intervention Type DRUG

Cases will receive 10 mg intravenous metoclopramide every 6 hours.

Control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Metoclopramide

Cases will receive 10 mg intravenous metoclopramide every 6 hours.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Khadija Mohammed Elbaradei

Resident of Anesthesia, Surgical Intensive Care and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University Hospitals

Tanta, ElGharbiaa, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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35298/2/22

Identifier Type: -

Identifier Source: org_study_id

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