Protocol summary

Summary
Postoperative rhythm disorders are a serious complication of open-heart surgery. The incidence of postoperative supraventricular arrhythmias has been reported to be 11–54%, and the incidence of ventricular arrhythmia to be 1.8–13%.because of high prevalence of cardiac arrhythmia after CABG, this study aimed to investigate the use of prophylactic magnesium sulphate on treating arrhythmias that may occur following coronary bypass grafting operations. In this double blind randomized trial study, 174 CABG candidates recruited. Renal or heart failure patients excluded from the study. As well as who had the history of taking antiarrythmic drug .All participants divided in two groups. 87 patients were given 3 g of magnesium sulphate diluted in 100 cc of isotonic 0.9% solution intravenously for 2 hours at the following times: 12 hours prior to the operation, immediately following the operation, and on postoperative days 1, 2, and 3 (Group 1). The other group of 87 patients was given 100 cc. isotonic 0.9% as placebo, during the same time periods. Patients were monitored during the preoperative period and for at least 24 hours postoperatively. The rhythm follow-up of cases was confirmed by ECG at 0, 6, and 12 hours postoperatively, as well as on postoperative days 1, 2, and 3. Magnesium blood ion analysis: plasma Mg+2 levels were determined by spectrophotometric analysis of venous blood samples taken immediately after the operation and on postoperative days 1, 2, and 3. Total Mg+2 levels were recorded. At the same time, levels of Na+, K+, and Ca+2 were also determined, and their insufficiencies replaced in the patients. During the study PVC / min , VT,NSVT ,VF and AF were monitored and recorded in patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104106159N1
Registration date: 2011-05-11, 1390/02/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-05-11, 1390/02/21
Registrant information
Name
Mohammad Ruzbahani
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1822 0291
Email address
dr-ruzbahani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
kermanshah University of Medicine Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-05-05, 1390/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of magnesium prophylaxis on cardiac arrythmia after CABG
Public title
Efficacy of magnesium prophylaxis on cardiac arrhythmia after by-pass coronary artery operations
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:l pateint candidate for coronary artery by-pass graft Exclusion criteria:renal and heart failure and history of arrythmia,used of anti arrythmic drug ,implantable cardiovertor deffibllirator
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 178
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee
Street address
Kermanshah University Of Medical Sciences
City
Kermanshah
Postal code
Approval date
2010-12-13, 1389/09/22
Ethics committee reference number
پ/7/420/713

Health conditions studied

1

Description of health condition studied
cardic arrhythmia
ICD-10 code
I47.2
ICD-10 code description
Ventricular tachycardia

2

Description of health condition studied
cardic arrhythmia
ICD-10 code
I48
ICD-10 code description
فیبریلاسیون و فلاتر دهلیزی

3

Description of health condition studied
cardic arrhythmia
ICD-10 code
I49.0
ICD-10 code description
فیبریلاسیون و فلاتر بطنی

4

Description of health condition studied
cardic arrhythmia
ICD-10 code
I49.1
ICD-10 code description
ضربان زودرس دهلیزی

5

Description of health condition studied
cardic arrhythmia
ICD-10 code
I49.3
ICD-10 code description
ضربان زودرس بطنی

Primary outcomes

1

Description
atrial fibrillation,atrial flutter.ventricular fibrillation,ventricular tackycardia,prematur ventricular complex,non sustained ventricular tackycardia
Timepoint
24hour
Method of measurement
monitoring

Secondary outcomes

1

Description
cognitive status
Timepoint
daily
Method of measurement
Examination

2

Description
coagebility status
Timepoint
daily
Method of measurement
lab

3

Description
neurological status
Timepoint
daily
Method of measurement
examination

Intervention groups

1

Description
87 patients were given 3 g of magnesium sulphate (MgSO4) [20 ml = 24.32 mEq/L Mg+2] in 100 cc of isotonic 0.9% solution over 2 hours intravenously at the following times: 12 hours prior to the operation, immediately following the operation, and on postoperative days 1, 2, and 3(intervention group).
Category
Prevention

2

Description
87patients were given 100 cc of isotonic 0.9% solution over 2 hours intravenously at the following times: 12 hours prior to the operation, immediately following the operation, and on postoperative days 1, 2, and 3 (placebo group)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
KERMANSHAH EMAM ALI HOSPITAL
Full name of responsible person
MOHAMMAD RUZBAHANI MD
Street address
KERMANSHAH EMAM ALI HOSPITAL
City
KERMANSHAH

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Ruzbehani
Street address
EMAM ALI Hospital
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mostafa Bahreman
Position
Lecturer
Other areas of specialty/work
Street address
EMAM ALI HOSPITAL
City
Kermanshah
Postal code
6715847125
Phone
+98 918 859 1451
Fax
Email
DR-bahremand@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mostafa Bahremand
Position
Lucturer
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6715847125
Phone
+98 918 859 1451
Fax
Email
DR-bahremand@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mohammad Ruzbehani
Position
Cardiology Resident
Other areas of specialty/work
Street address
Emam Ali Hospital
City
Kermanshah
Postal code
6715847125
Phone
+98 83 1822 0291
Fax
+98 83 1836 2022
Email
DR_Ruzbahani@yahoo.com
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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