NCT04873297

Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke Patients Fed Via Nasogastric Tubes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Acute Stroke
• Aspiration Pneumonia

Interventions

Type	Name	Description
DRUG	Metoclopramide 10mg	Tab. Metoclopramide 10mg TDS via NG tube
DRUG	Placebo	Placebo 10 ml of plain water Via NG

Timeline

• Start date: 2021-05-02
• Primary completion: 2021-10-02
• Completion: 2021-10-02
• First posted: 2021-05-05
• Last updated: 2021-10-19

Locations

1 site across 1 country: Pakistan