Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

Shaheed Zulfiqar Ali Bhutto Medical University106 enrolled

Overview

Pneumonia is a major cause of mortality and morbidity in patients with acute stroke fed via nasogastric tubes and may be because of vomiting and gastro-esophageal regurgitation. The aim of the study was to assess whether regular treatment with metoclopramide, a D2-receptor antagonist with antiemetic and gastric prokinetic actions, could reduce the rate of pneumonia.

Patients admitted with no signs of pneumonia within 7 days of stroke onset and 48 hours of insertion of a nasogastric tube will be recruited into a single-blind randomized placebo-controlled study who will admit in Neurology Department, PIMS. Participants will receive metoclopramide 10 mg or placebo 3 times daily via the nasogastric tube for 4 days. Clinical signs of pneumonia will be recorded on alternate days. Pneumonia will be diagnosed if the patient has relevant clinical signs, high inflammatory markers, and new infiltrates on the chest radiograph. A sample size of 106 patients is calculated, 53 patients in each group. Non-probability consecutive sampling will be used for recruitment of participants. Study duration will be six months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

106

Conditions

Acute Stroke Aspiration Pneumonia

Interventions

Metoclopramide 10mgDRUG

Tab. Metoclopramide 10mg TDS via NG tube

PlaceboDRUG

Placebo 10 ml of plain water Via NG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients of either gender. 2. Patients within 7 days of acute ischemic or hemorrhagic stroke confirmed by computed tomographic scan of the brain who required nasogastric feeds for \>24 hours, and could be recruited within 48 hours of NGT insertion 3. Age above 13 years. Exclusion Criteria: * Patients with aspiration pneumonia at the time of presentation. * Patients with a history of chronic neurodegenerative diseases that could affect swallowing (e.g. Parkinson disease and motor neuron disease) * Poor postural control (unable to sit up for swallowing assessment). * Esophageal disorders, * Contraindications to metoclopramide.

Locations (1)

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan

Outcomes

Primary Outcomes

Number of episodes of aspiration pneumonia

Number of episodes of aspiration pneumonia will be observed after treatment with metoclopramide.

Time frame: 7 days

Secondary Outcomes

Number of participants with swallowing improved +NGT removed

During admission patient's swallowing with improved and NG tube removed.

Time frame: 7 days

Number of participants with treatment withdrawn and NGT removed

Patient's swallowing with improved and treatment withdrawn and NG tube removed.

Time frame: 7 days

New onset of Fever

Aspiraton pneumonia will be assess in terms of fever (\>98.6F)

Time frame: 7 days

Leukocytosis

Aspiration pneumonia will be assess in terms of leukocytosis on blood counts \[ TLC \>12000/uL\]

Time frame: 7 days

Aspiration Pneumonia

Treatment with metoclopramide in patients with acute stroke is hypothesized to prevent aspiration pneumonia and pneumonia will be assess in terms of new findings on chest x-ray of patients \[The posterior segment of the upper lobes and the superior segment of the lower lobes are most commonly involved lung sites when aspiration occurs in a recumbent patient. In an erect patient, aspiration is more likely to involve bilateral basal segments, middle lobe, and lingula- new exudate, new pleural effusion and new infiltrates\]

Time frame: 7 days

Data from ClinicalTrials.gov

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