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Evaluation of intravenous magnesium sulphate in clinical improvement of patients, with acute stroke

Protocol summary

Summary
Background: This study evaluated the effect of intravenous magnesium sulphate in clinical improvement of the patients with acute stroke. In various studies, there is a lot of information about the use of magnesium sulphate in different conditions of brain ischemia. while neuroprotective effects of magnesium sulphate as a neuroprotective agent has been demonstrated in focal and global brain ischemia, in animal models, but the effect of this agent is still unclear. Methods: 80 patients (In this study, 47 percent of patients was female and 53 percent was male) of with acute ischemic stroke signs and symptoms lasting less than 12 hours were included in the study and were divided into two groups, 40 patients received 4 g of MgSO4 over 15 minutes and then 16 g over the next 24 hours, and 40 patients were received placebo. Results: the results show that the rate of clinical improvement was better in group with magnesium sulphate, than the control group.The highest correlation of magnesium sulphate was associated with improvement of upper and lower muscle forces and aphasia and level of consciousness of patients results. The results showed that, in the group with magnesium sulphate, the patients with Grade III decreased and the patient with Grade II , I increased. After 2 weeks in this Group the patients with Grade III, decreased to 12.5 percent and the patients with Grade II and I, increased to 50 percent and 37.5 percent.(According to national institutes of health stroke scale). Conclusion: According to this study,magnesium sulphate,can be used as a neuroprotective agent in patients with acute stroke. Key words: magnesium sulphate, stroke, neuroprotective

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014060117945N1
Registration date: 2014-07-20, 1393/04/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-20, 1393/04/29
Registrant information
Name
Ghasem Fattahzadeh Ardalani
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1552 2086
Email address
gh.fattahzadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2013-08-21, 1392/05/30
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intravenous magnesium sulphate in clinical improvement of patients, with acute stroke
Public title
Evaluation of intravenous magnesium sulphate in clinical imrovement of patients, with acute stroke, in Ardabil Alavi hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age greater than 18 years old; Age less than 80 years old; onset of symptoms less than 12 hour . Exclusion criteria: : Patient with chronic renal failure (more than 5.2); pregnant patients; patients with brain hemorrhage; age less than 18 years old; systolic blood pressure greater than 220 and diastolic lower than 90; patient with severe respiratory disease; patient with heart block; Patients with pre-existing neurological disease or progressive systemic disease that can impair neurological assessment.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Department of Neurology, Alavi hospital
City
Ardebil
Postal code
Approval date
2013-07-14, 1392/04/23
Ethics committee reference number
9108

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
I64
ICD-10 code description
Accident - vascular, brain

Primary outcomes

1

Description
Degree of limb paresis
Timepoint
Admission - three days later - two weeks later
Method of measurement
Standard questionnaire NIHSS

2

Description
Aphasia
Timepoint
Admission - three days later - two weeks later
Method of measurement
Standard questionnaire NIHSS

3

Description
level of consciousness
Timepoint
Admission - three days later - two weeks later
Method of measurement
Standard questionnaire NIHSS

Secondary outcomes

1

Description
The rate of cerebral ischemia.
Timepoint
3 day later - 2 week later
Method of measurement
CT-scan

Intervention groups

1

Description
In the control group the same amount of volume, not weight of normal saline solution over 15 minutes and then within 24 hours for patient was given.
Category
Placebo

2

Description
In the intervention group magnesium sulfate vials has been given for the patient that have stroke in last 12 hour, 4 g intravenous magnesium sulfate in less than 15 minute and then 16 g within 24 hour has been given, the patients was controlled in admission and 3 day later and 2 week later.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alavi hospital
Full name of responsible person
Dr Ghasem Fattahzadeh
Street address
Ardabil Alavi hospital
City
Ardebil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Ghasem Fattahzadeh Ardalani
Street address
Ardabil Alavi hospital
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Ghasem Fattahzadeh Ardalani
Position
Assistant Professor
Other areas of specialty/work
Street address
Ardabil Alavi hospital
City
Ardebil
Postal code
Phone
+98 45 1224 8888
Fax
Email
Gh.fattahzadeh@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Ghasem Fattahzadeh Ardalani
Position
Assistant Professor
Other areas of specialty/work
Street address
Ardabil Alavi hospital
City
Ardebil
Postal code
Phone
+98 45 1223 8888
Fax
Email
Gh.fattahzadeh@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Masoud Ghasemi
Position
General Physician
Other areas of specialty/work
Street address
fatemiyye Alley, Mobarezan Square, Ardabil, iran
City
Ardabil
Postal code
567636596
Phone
+98 914 157 0817
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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