Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

Shaheed Zulfiqar Ali Bhutto Medical University

Status and phase: Completed; Phase 4

Conditions: Aspiration Pneumonia; Acute Stroke

Treatments: Drug: Placebo; Drug: Metoclopramide 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04873297

Metoclopramide in Stroke

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups, including a placebo group

Metoclopramide Group

Experimental group

Description:

One group will be given metoclopramide 10mg TDS

Treatment:

Drug: Metoclopramide 10mg

Placebo Group

Placebo Comparator group

Description:

This group will be given placebo (normal saline 10ml via NG TDS)

Treatment:

Drug: Placebo