IV Injection of Metoclopramide With or Without Dexamethasone

Ahmed Nassar Ibrahim Mohammed

Status and phase: Begins enrollment in 4 months; Early Phase 1

Conditions: Trauma Injury

Treatments: Combination Product: Dexamethasone; Diagnostic Test: Ultrasonography assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT07343817

Anesthesia Department

Details and patient eligibility

About

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.

Full 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
  <!-- -->
  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.

Enrollment: 1 estimated patient

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1 participants in 2 patient groups

Metoclopramide

Experimental group

Description:

Drug used to assessment

Treatment:

Diagnostic Test: Ultrasonography assessment

Combination Product: Dexamethasone

Dexamethasone

Experimental group

Description:

Drug used to assessment

Treatment:

Diagnostic Test: Ultrasonography assessment

Combination Product: Dexamethasone