This study investigated the effect of magnesium in reducing arrhythmia after CABG surgery on 140patients undergoing elective surgery were to be done in Imam Khomeini hospital of Ardabil .Based on initial blood levels of magnesium, patients are divided into two main groups of normo-Magnesium and hypo-Magnesium.Magnesium Blood levels of hypo-Magnesium patients corrected with administration of 2 g of magnesium sulfate.Then both main groups undergo surgery with normal blood levels .
After surgery, both groups were randomly divided into two sub-groups.in one Sub-group 2 grams of magnesium sulfate intravenously in a single dose, given for prophylaxis , and next sub-group in the same amount of distilled water as a placebo given intravenously.This process done on both subgroups of the main groups .Then, this four sub-groups will be monitored for the occurrence of arrhythmias , blood levels of magnesium and complications for three days .Finally, the results are interpreted and compared according to the the subgroup.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092224133N1
Registration date:2015-10-05, 1394/07/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-05, 1394/07/13
Registrant information
Name
Farshad Tofighi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 5561
Email address
farshad.to02@gmail.com
Recruitment status
Recruitment complete
Funding source
Governmental-Ardabil University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of magnesium in reducing arrhythmias in patients after CABG surgery
Public title
The effect of magnesium in post-CABG arrhythmias
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion :1- All patients candidate elective CABG surgery Cardiac Surgery
2-Primary blood levels of magnesium
exclusion : death in the CABG surgery or during the 12 hours after surgery
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Janbazan Square, Daneshgah Avenue, opposite Shorabil, University of Medical Sciences, Faculty of Medicine and Paramedical
City
Ardabil
Postal code
5618953141
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
IR.ARUMS.REC.1394.20
Health conditions studied
1
Description of health condition studied
Ventricular premature depolarization
ICD-10 code
I49.3
ICD-10 code description
Ventricular premature depolarization
2
Description of health condition studied
Atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
Cardiac arrhythmia
Timepoint
3 days after surgery
Method of measurement
Electrocardiogram
Secondary outcomes
1
Description
Blood levels of magnesium
Timepoint
daily for 3 day
Method of measurement
Milligrams per deciliter by arterial blood samples
Intervention groups
1
Description
2 g of magnesium sulfate prescribed in the intervention group before and after surgery, intravenous, single dose
Category
Prevention
2
Description
In the control group administered 2 g of distilled water before and after surgery, intravenous, single dose
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital of Ardabil
Full name of responsible person
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Parvaneh naft-chi
Street address
School of Medical -Research Unit
City
Ardabil
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
Farshad Tofighi
Position
Student of medicine
Other areas of specialty/work
Street address
Janbazan Square, Daneshgah Avenue, opposite Shorabil, University of Medical Sciences, Faculty of Medicine and Paramedical
City
Ardabil
Postal code
Phone
+98 45 3351 2000
Fax
Email
researchmed@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 Alireza mohammadzadeh
Position
Heart Surgery Subspeciality
Other areas of specialty/work
Street address
Janbazan Square, Daneshgah Avenue, opposite Shorabil, University of Medical Sciences, Faculty of Medicine and Paramedical
City
Ardabil
Postal code
Phone
+98 45 3351 2000
Fax
Email
researchmed@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farshad Tofighi
Position
Student of medicine
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)