IV Injection of Metoclopramide With or Without Dexamethasone
Ultrasonic Evaluation of Metoclopramide With or Without Dexamethasone on Gastric Motility in Traumatic Patients
Reflux and the aspiration of gastric contents have always been important focal points. Previous study stated that trauma is an important factor in aspiration pneumonia.
Often, emergency trauma patients have residual gastric contents due to the ingestion of food before injury, the accidental swallowing of nasal and/or oral blood after injury, and delayed gastric emptying due to stress, pain, or the use of opioids.
During sedation or general anesthesia, such satiated patients are often at risk of aspiration due to a reduction in lower esophageal sphincter tension and the protective inhibition of the airway reflex.
Perioperative gastric ultrasound can be performed at a bedside ultrasound unit; it can safely, non-invasively, conveniently, and effectively evaluate the fullness of a patient's stomach and the nature of their gastric contents.
It can also be used in the selection of an appropriate method for the anesthetic induction process and can reduce the risk of vomiting, aspiration, and related complications.
As a gastric motility-promoting drug, metoclopramide can accelerate gastric emptying.
Dexamethasone reduced the incidence of nausea and vomiting and improve gastric motility.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PATIENTS AND METHODS Study design / Prospective randomized controlled trial study sitting/this study will be conducted in Assiut University Trauma Center Hospital.
Patients will be randomly allocated into two groups:
- Group (1) : intravenous infusion of metoclopramide 8mg
Group (2) : intravenous infusion of metoclopramide 8mg with infusion of dexamethasone 8mg INCLUSION CRITERIA
- Traumatic patients undergo emergency operations
- 18-60 years of age
- 155-180 cm in height
- Body mass index <30 kg/m2 EXCLUSION CRITERIA
- A history of diseases of important organs, such as diabetes, gastro-paresis, liver and kidney dysfunction, and cardiopulmonary insufficiency.
- Contraindications for metoclopramide or dexamethasone treatment.
- Taking opioids or drugs that affect gastric motility.
- A history of esophageal, gastric, or upper abdominal surgery.
- A need for immediate emergency surgery, resulting in insufficient study time (120 min).
- Inability of the patient or their family to understand the study protocol.
TECHNICAL PROCEDURES
All patients who will be admitted to Assiut University Trauma Center Hospital included in this study will be connected to non-invasive blood pressure, ECG, and pulse oximetry then divided into two groups:
Group (1): Receive intravenous infusion of metoclopramide 8mg Group (2): Receive intravenous infusion of metoclopramide 8mg with infusion of dexamethasone 8mg Then these patients will be examined by ultrasound (S-Nerve Series, Sono Co., Ltd., China, fitted with a 3-5 MHz convex array probe).
The probe will be placed in the sagittal position under the xiphoid process next to the upper abdomen, and the abdominal imaging mode will be selected.
The left lobe of the liver and the abdominal aorta are anatomical marks on the section of the ultrasound image.
First, the patient will be placed in a supine position and undergo a qualitative evaluation of the gastric antrum (to determine gastric contents, i.e., liquids and solids).
Then, the cross sectional area (CSA) of the gastric antrum will be measured during the interval of gastric peristalsis.
The measurement range will be from the sub-serosa to the serosa, and the average value of three measurements will be taken as the result.
Then the patient will be placed in a half-sitting/half-lying position (the head of the bed will be raised by 45°.
These steps will be repeated, and the inspection time will be limited to 5 min. All patients who met the inclusion and exclusion criteria will be fasted (food and liquids) before the procedure and won't receive any opioids or medications that might affect gastrointestinal motility.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Ahmed Nassar, Student
- Phone Number: 00201014421973
- Email: amm7.nassar@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Traumatic patients undergo emergency operations
- 18-60 years of age
- 155-180 cm in height
- Body mass index <30 kg/m2
Exclusion Criteria:
- A history of diseases of important organs, such as diabetes, gastro-paresis, liver and kidney dysfunction, and cardiopulmonary insufficiency.
- Contraindications for metoclopramide or dexamethasone treatment.
- Taking opioids or drugs that affect gastric motility.
- A history of esophageal, gastric, or upper abdominal surgery.
- A need for immediate emergency surgery, resulting in insufficient study time (120 min).
- Inability of the patient or their family to understand the study protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Metoclopramide
Drug used to assessment
|
IV infection
Other Names:
Assessment of gastric motility by ultrasonography
|
|
Experimental: Dexamethasone
Drug used to assessment
|
IV infection
Other Names:
Assessment of gastric motility by ultrasonography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of gastric weight/volume kg/m^2 measured by ultrasonography in traumatic patients.
Time Frame: 2 years
|
Assessment of gastric weight/volume kg/m^2 by grams measured by ultrasonography in traumatic patients.
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Accidental Injuries
- Organic Chemicals
- Hydrocarbons
- Hydrocarbons, Cyclic
- Carboxylic Acids
- Hydroxy Acids
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Amides
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Phenols
- Benzene Derivatives
- Pregnadienetriols
- Acids, Carbocyclic
- para-Aminobenzoates
- Aminobenzoates
- Benzoates
- Hydroxybenzoates
- Phenyl Ethers
- Benzamides
- Chlorobenzoates
- Hydroxybenzoate Ethers
- Dexamethasone
- Metoclopramide
Other Study ID Numbers
- Anesthesia Department
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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