The aim of this study is comparing the prophylaxis effects of Metoprolol and Magnesium on prevention of atrial fibrillation after CABG (coronary artery bypass graft). A study is double-blind randomized clinical trial. 195 patients, randomized into 3 groups Metoprolol, Magnesium and a combination of the Metoprolol and Magnesium. In the first group inject 5mg Metoprolol , in second group inject 1.5 grams Magnesium and third group inject combination 2.5 mg Metoprolol and 1 grams Magnesium . Inclusion criteria: All patients undergoing non-emergency CABG; all patients in ASA class 3 and 4; all patients during surgery is less than 6 hours; all patients without previous history of arrhythmia and atrial fibrillation ; patients without history the anti-arrhythmia Exclusion criteria: All patients during surgery have more than 6 hours; patients undergoing emergency CABG; patients who are undergoing CABG addition valve replacement surgery; patients with a history of previous arrhythmia and AF had before surgery; patients who have a history of taking drugs arrhythmia; patients who have a history of allergy to Magnesium and Metoprolol .Atrial fibrillation record researcher prescript Amiodarone (300 mg) for treatment .vital signs in and after operation and atrial fibrillation after operation compare in 3 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031520258N5
Registration date:2016-04-17, 1395/01/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-04-17, 1395/01/29
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the prophylaxis effects of Metoprolol and Magnesium on prevention of atrial fibrillationafter CABG ( coronary artery bypass graft)
Public title
Comparing the prophylaxis effects of Metoprolol and Magnesium on prevention of AFatrial fibrillation after CABG ( coronary artery bypass graft)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients undergoing non-emergency CABG; all patients in ASA class 3 and 4; all patients during surgery is less than 6 hours; all patients without previous history of arrhythmia and atrial fibrillation ; patients without history the anti-arrhythmia Exclusion criteria: All patients during surgery have more than 6 hours; patients undergoing emergency CABG; patients who are undergoing CABG addition valve replacement surgery; patients with a history of previous arrhythmia and AF had before surgery; patients who have a history of taking drugs arrhythmia; patients who have a history of allergy to Magnesium and Metoprolol
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
195
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Postal code
848176941
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
1394.296.IR.ARAKMU.REC
Health conditions studied
1
Description of health condition studied
atrial fibrillation
ICD-10 code
T82.8
ICD-10 code description
Other specified complications of cardiac and vascular prosthetic devices, implants and grafts
Primary outcomes
1
Description
atrial fibrillation
Timepoint
in operation and after operation until 3 day
Method of measurement
Electrocardiography
2
Description
pulse of heart
Timepoint
in operation and after operation until 3 day
Method of measurement
count
3
Description
respiratory
Timepoint
in operation and after operation until 3 day
Method of measurement
observation
4
Description
Temperature
Timepoint
in operation and after operation until 3 day
Method of measurement
Thermometer
5
Description
blood pressure
Timepoint
in operation and after operation until 3 day
Method of measurement
Barometer
Secondary outcomes
empty
Intervention groups
1
Description
In the first group inject 5mg Metoprolol
Category
Treatment - Drugs
2
Description
In second group inject 1.5 grams Magnesium
Category
Treatment - Drugs
3
Description
Third group inject combination 2.5 mg Metoprolol and 1 grams Magnesium
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Azade Hosseini
Street address
Sardasht, Basij squre,Amiralmomenin hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences