Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Stroke
- Aspiration Pneumonia
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: After taking permission from the Hospital Ethical Committee this study will be conducted at the Neurology department of PIMS. After informed written consent, all patients admitted to the Neurology ward with acute stroke on the basis of the clinical and radiologic evidence as defined in the operational definition will undergo detailed history and neurological examination. Patients beings grouped into 2 subgroup via lottery method. One group is given metoclopramide and one group will be given placebo (normal saline). SPSS version 23 will be used for data analysis. Post stratification chi square test will be applied. P value ?0.05 will be considered significant.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04873297
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Muhammad Hassan, MD Shaheed Zulfiqar Ali Bhutto Medical University
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