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The Comparison between oral magnesium supplement before surgery and IV administration of magnesium during induction in prevention of hypomagnesemia and arrhythmia after coronary surgery in hospitals related to Shiraz University of Medical sciences

Protocol summary

Summary
This is a RCT study with 2 groups (intervention and control) that the intervention group receives magnesium hydroxide before operation and the control group receives mgso4 after induction of anesthesia. The sample size is at least 36 in each group that it is increased to 43 considering loss to follow up rate of 20%. The goals are: studying the effects of oral magnesium in prevention of arrhythmia and decreasing in hypomagnesaemia rate after CABG, studying intravenous magnesium effects in prevent of arrhythmia and hypomagnesaemia after CABG. The patient who is candidate for CABG enters the study. If one of them has the history of arrhythmia that did not treat, having the history of renal failure or liver dysfunction, patients who have re-operation after main operation, patients who have received b-blocker or ca–blocker before operation because of arrhythmia and patients who are treated with magnesium before operation are excluded from study. The interventions which were done in this study include: taking blood sample for serum magnesium examination and taking electrocardiogram before operation, giving oral magnesium supplement (MOM) to the intervention group before operation and intravenous magnesium (mgso4) to the control group, taking serum magnesium sample during rewarming when the patient is under CPB, checking EKG monitoring for finding existence of arrhythmia before ,during and after CPB , taking serum magnesium sample at the entrance to the intensive unit care (ICU) and repeat it 6,12,24 and 48 hours after this ,taking EKG the entrance time ,24 and 48 hours after it and checking them for presence f arrhythmia.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015052122359N1
Registration date: 2015-11-11, 1394/08/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-11, 1394/08/20
Registrant information
Name
Lale Eshaqi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 198 5893
Email address
stud2992736228@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison between oral magnesium supplement before surgery and IV administration of magnesium during induction in prevention of hypomagnesemia and arrhythmia after coronary surgery in hospitals related to Shiraz University of Medical sciences
Public title
Comparison between oral and IV infusion of magnesium on arrhythmia and hypomagnesemia after heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:All patients who are candidates for Coronary Artery Bypass Grafts in Shiraz University of Medical Sciences hospitals without Renal Failure, liver failure,no B- blocker or Ca- blocker preoperatively cause of arrhythmia, no preoperative Magnesium therapy . Exclusion criteria: Re-operation after main surgery because of hemorrhage, IABP usage .
Age
From 40 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences.
Street address
Zand , St.
City
Shiraz
Postal code
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.SUMS.REC.1394.9

Health conditions studied

1

Description of health condition studied
Arrhythmia
ICD-10 code
I20,I21,I2
ICD-10 code description
Ischaemic heart diseases

2

Description of health condition studied
hypomagnesemia
ICD-10 code
E87.8
ICD-10 code description
Other disorders of electrolyte and fluid balance, not elsewhere classified

Primary outcomes

1

Description
Serum magnesium level
Timepoint
pre operation,during cardiopulmonary bypass and 6,12,24,48 hours after CABG
Method of measurement
Serum Magnesium has been tested with dirui-cs800 set and with xylidyl blue test.

2

Description
Heart rhythm
Timepoint
48 hours after CABG
Method of measurement
Heart monitoring

Secondary outcomes

empty

Intervention groups

1

Description
Mg-so4 20% was given to the 43 patients in control group after anesthesia induction. Then during CPB, before rewarming take the blood sample and after opening cross clamp . 2gr Mgso4 inserted to the circuit.At the end of operation in ICU took another sample. Other samples have been taken after 6.12,24 and 48 hours after surgery. EKG-monitoring was done during these 2 days.
Category
Treatment - Drugs

2

Description
20-30cc Mg- Hydroxide15% was given to the intervention group with NGT after anesthesia induction. Then during CPB, before rewarming take the blood sample and after opening cross clamp . 2gr Mgso4 20% inserted to the circuit.At the end of operation in ICU took another sample. Other samples have been taken after 6.12,24 and 48 hours after surgery. EKG-monitoring was done during these 2 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Janati Mansor
Street address
Namazi hospital ,Namazi square .
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shiraz University of Medical Sciences
Full name of responsible person
Postforosh
Street address
Zand, St
City
Shiraz
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,Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Janati Mansor
Position
Associate Professor of cardiovascular surgery
Other areas of specialty/work
Street address
Namazi hospital ,Namazi square .
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
janatim@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Janati Mansor
Position
Associate Professor of cardiovascular surgery
Other areas of specialty/work
Street address
Namazi hospital ,Namazi square .
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
janatim@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Eshaqi Lale
Position
Master student of Perfusion
Other areas of specialty/work
Street address
Namazi ,hos. Namazi square .
City
Shiraz
Postal code
Phone
Fax
Email
l.eshaqi@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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