Trauma InjuryEarly Phase 1NCT07343817
IV Injection of Metoclopramide With or Without Dexamethasone
A Early Phase 1 study testing Dexamethasone and Ultrasonography assessment in people with Trauma Injury, run by Ahmed Nassar Ibrahim Mohammed.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Dexamethasone and Ultrasonography assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Apr 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Traumatic patients undergo emergency operations
- 18-60 years of age
- 155-180 cm in height
- Body mass index <30 kg/m2
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Trauma Injury
- Being tested
- Dexamethasone, Ultrasonography assessment
- Keywords
- Poly trauma
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneCombination product
Also called Metoclopramide
IV infection
Ultrasonography assessmentDiagnostic test
Assessment of gastric motility by ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide | Experimental | Drug used to assessment Receives: Combination Product: Dexamethasone; Diagnostic Test: Ultrasonography assessment |
| Dexamethasone | Experimental | Drug used to assessment Receives: Combination Product: Dexamethasone; Diagnostic Test: Ultrasonography assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of gastric weight/volume kg/m^2 measured by ultrasonography in traumatic patients.
Assessment of gastric weight/volume kg/m^2 by grams measured by ultrasonography in traumatic patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Nassar Ibrahim Mohammed
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Ahmed Nassar Ibrahim Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343817
- Sponsor's protocol ID
- Anesthesia Department
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Evaluation of Metoclopramide With or Without Dexamethasone on Gastric Motility in Traumatic Patients
- ClinicalTrials.gov ID
- NCT07343817
- Acronym / sponsor ID
- Anesthesia Department
- Conditions
- Trauma Injury
- Keywords
- Poly trauma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Ahmed Nassar Ibrahim MohammedUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide | Experimental | Combination Product: Dexamethasone, Diagnostic Test: Ultrasonography assessmentDrug used to assessment |
| Dexamethasone | Experimental | Combination Product: Dexamethasone, Diagnostic Test: Ultrasonography assessmentDrug used to assessment |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Traumatic patients undergo emergency operations
- 18-60 years of age
- 155-180 cm in height
- Body mass index <30 kg/m2
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: MetoclopramideIV infection | Combination product | Dexamethasone, Metoclopramide |
| Ultrasonography assessmentAssessment of gastric motility by ultrasonography | Diagnostic test | Dexamethasone, Metoclopramide |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone and Ultrasonography assessment in people with Trauma Injury, run by Ahmed Nassar Ibrahim Mohammed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Nassar, Student (00201014421973, amm7.nassar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of gastric weight/volume kg/m^2 measured by ultrasonography in traumatic patients. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.