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Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

NCT ID: NCT04873297

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-02

Study Completion Date

2021-10-02

Brief Summary

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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

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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

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Acute Stroke Aspiration Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Metoclopramide Group

One group will be given metoclopramide 10mg TDS

Group Type EXPERIMENTAL

Metoclopramide 10mg

Intervention Type DRUG

Tab. Metoclopramide 10mg TDS via NG tube

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 10 ml of plain water Via NG

Interventions

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Metoclopramide 10mg

Tab. Metoclopramide 10mg TDS via NG tube

Intervention Type DRUG

Placebo

Placebo 10 ml of plain water Via NG

Intervention Type DRUG

Other Intervention Names

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Metomide Metoclop Water

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaheed Zulfiqar Ali Bhutto Medical University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Hassan

Resident in Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Shaheed Zulfiqar Ali Bhutto Medical University

Locations

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Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Metoclopramide in Stroke

Identifier Type: -

Identifier Source: org_study_id