A Phase 4 interventional study of Metoclopramide 10mg and Placebo in Acute Stroke and Aspiration Pneumonia, sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Shaheed Zulfiqar Ali Bhutto Medical University · Phase 4, Interventional, and Prevention
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 106 is close to the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Shaheed Zulfiqar Ali Bhutto Medical University is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
One group will be given metoclopramide 10mg TDS
Drug: Metoclopramide 10mg
This group will be given placebo (normal saline 10ml via NG TDS)
Drug: Placebo
Tab. Metoclopramide 10mg TDS via NG tube
Also known as: Metomide, Metoclop
Placebo 10 ml of plain water Via NG
Also known as: Water
Number of episodes of aspiration pneumonia
Number of episodes of aspiration pneumonia will be observed after treatment with metoclopramide.
Time frame: 7 days
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
Plan to share: No
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Shaheed Zulfiqar Ali Bhutto Medical University