IV Injection of Metoclopramide With or Without Dexamethasone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone, Ultrasonography assessment.
- Who it may be relevant to
- Registry conditions: Trauma Injury. Basic parameters: 16 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultrasonic Evaluation of Metoclopramide With or Without Dexamethasone on Gastric Motility in Traumatic Patients
Overview
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
1. Traumatic patients undergo emergency operations 2. 18-60 years of age 3. 155-180 cm in height 4. Body mass index \<30 kg/m2 EXCLUSION CRITERIA
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1. A history of diseases of important organs, such as diabetes, gastro-paresis, liver and kidney dysfunction, and cardiopulmonary insufficiency. 2. Contraindications for metoclopramide or dexamethasone treatment. 3. Taking opioids or drugs that affect gastric motility. 4. A history of esophageal, gastric, or upper abdominal surgery. 5. A need for immediate emergency surgery, resulting in insufficient study time (120 min). 6. 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.
Interventions
- Combination product Dexamethasone
IV infection - Diagnostic test Ultrasonography assessment
Assessment of gastric motility by ultrasonography
Primary outcome measures
- Assessment of gastric weight/volume kg/m^2 measured by ultrasonography in traumatic patients. [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07343817 · Anesthesia Department