This is a randomized double blind clinical trial study which will be conducted on 120 patients undergoing elective coronary artery bypass graft (CABG) surgery at Mazandaran Heart center, Sari, Iran. 120 Patients who meet inclusion criteria randomly divided into 3 equal groups. Group 1, 2 and 3 respectively receive 60, 80 and 100 mg/kg magnesium sulfate via cardioplegic solution during aortic cross clamp. Then all patients will be monitored for 3 days after surgery regarding occurrence of postoperative atrial fibrillation (AF). After collecting and classifying of information, data will be analyzed with SPSS18.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211124365N15
Registration date:2012-12-15, 1391/09/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-15, 1391/09/25
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of optimal prophylactic dose of magnesium sulfate for prevention of atrial fibrillation after CABG surgery
Public title
Determination of optimal prophylactic dose of magnesium sulfate for prevention of atrial fibrillation after CABG surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: signing informed consent; candidate for elective CABG based on angiography; use of cardiopulmonary bypass (CBP) during surgery; no previous history of any cardiac dysrhythmias that is under treatment ( including AF); hemodynamic stability ( MAP>50, heart rate between 50-110); age between 35&75 years old.
Exclusion criteria: history of heart failure (Ejection Fraction less than 30%); more than 4 grafts; renal failure ( serum creatinine >1.5 in two consecutive test); hepatic failure ( liver function tests more than 1.5 times of normal value); history of COPD; hyperthyroidism; serum PH < 7.25 or > 7.55; postoperative MI; second or third degree AV block; need for pacemaker after surgery; reoperation for any reason; history of pervious cardiac surgery; anti-arrhythmic drugs consumption (except beta blocker).
Age
From 35 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethic committee of Mazandaran University of Medical Sciences
Street address
Moallem Square, Mazandaran University of Medical Sciences
City
Sari
Postal code
46175866
Approval date
2011-02-05, 1389/11/16
Ethics committee reference number
89-130
Health conditions studied
1
Description of health condition studied
Atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
Atrial fibrillation
Timepoint
up to 3 days after operation
Method of measurement
ECG monitoring
Secondary outcomes
1
Description
PH
Timepoint
Before Before trial, during the operation,1st day, 2nd day and 3th day after operation, during the operation,1st day, 2nd day and 3th day after operation
Method of measurement
Laboratory kit
2
Description
K
Timepoint
Before Before trial, during the operation,1st day, 2nd day and 3th day after operation, during the operation,1st day, 2nd day and 3th day after operation
Method of measurement
Laboratory kit - mEq/L
3
Description
Mg
Timepoint
Before Before trial, during the operation,1st day, 2nd day and 3th day after operation, during the operation,1st day, 2nd day and 3th day after operation
Method of measurement
Laboratory kit - mg/dl
Intervention groups
1
Description
Intervention 1: 60 mg/Kg MgSO4 via cardioplegic solution during cross clamping
Category
Prevention
2
Description
Intervention 2: 80 mg/Kg MgSO4 via cardioplegic solution during cross clamping
Category
Prevention
3
Description
Intervention 3: 100mg/Kg MgSO4 via cardioplegic solution during cross clamping
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandran Heart Center
Full name of responsible person
Afshin Gholipour Baradari, MD
Street address
Mazandaran Heart center, Artesh Blvd
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati, MD
Street address
Moallem Square, Mazandaran university of medical sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari, MD
Position
CCMF, Associate Professor, Chief of ICU
Other areas of specialty/work
Street address
Moallem Square, Mazandaran University of Medical Sciences