The present study will be a randomized clinical trial that designed to evaluate effect of magnesium therapy on coagulation profiles on system, we also measured serum magnesium to confirm the effect of magnesium therapy on rotational thromboelastometry (ROTEM) parameters. Before induction of anesthesia 4ml of whole blood will be obtained through veinopuncture from each patient for ROTEM analysis. The remaining blood samples will be sent to the laboratory to measure the serum magnesium concentration. After that, each patient in group A, will receive 50 ml syringe with A label that will be infused intravenously in 5 minutes and each patient in group B, will received 50 ml syringe with B label that was infused intravenously in 5 minutes. Then, again before surgical incision 4ml of whole blood was obtained through veinopuncture from each patient for ROTEM analysis measurement of serum magnesium.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012911662N9
Registration date:2016-01-30, 1394/11/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-30, 1394/11/10
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium sulfate on coagulation parameters of the ROTEM system during adult liver transplant anesthesia
Public title
Survey the effect of magnesium on coagulopathy of liver transplant patients.
Purpose
Treatment
Inclusion/Exclusion criteria
The eligible participants were all patients with end stage liver disease aged between 18 and 60 years old, who were candidates for orthotopic liver transplantation under general anesthesia.
Exclusion criteria were: having a history of hepatorenal syndrome types І and ІІ; baseline serum potassium >6 meq/l; ejection fraction <60% and cirrhotic cardiomyopathy and patients with INR <1.5.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Shiraz Medical School Research Ethic Committee
Street address
Shiraz Medical School, Zand Blvd.
City
Shiraz
Postal code
197871345
Approval date
2015-08-05, 1394/05/14
Ethics committee reference number
IR.sums.med.rec.1394.88
Health conditions studied
1
Description of health condition studied
Liver transplantation
ICD-10 code
Y83.0
ICD-10 code description
Surgical operation with transplant of whole organ
Primary outcomes
1
Description
Measurement of the coagulation profiles on rotational thromboelastometry (ROTEM) system.
Timepoint
First time, before magnesium sulfate infusion and induction of anesthesia and second time, after magnesium sulfate infusion just before surgical incision.
Method of measurement
By rotational thromboelastometry (ROTEM) system.
Secondary outcomes
1
Description
Measurement of the serum magnesium level.
Timepoint
First time, before magnesium sulfate infusion and induction of anesthesia and second time, after magnesium sulfate infusion just before surgical incision.
Method of measurement
In the lab by special kit.
Intervention groups
1
Description
Each patient in the intervention group , will received 1.5 gram magnesium sulfate that will be diluted with normal saline up to 50 ml with 50 ml syringe with B label that will be infused intravenously in 5 minutes.
Category
Treatment - Drugs
2
Description
Each patient in the control group, will receive 50 ml normal saline in 50 ml syringe with A label that will be infused intravenously in 5 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital Organ Transplantation Center
Full name of responsible person
Mohammad Ali Sahmeddini
Street address
Namazi Hospital, Namazi Sq
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University Of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology
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
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesilology and critical care Research center, Namazi Hospital, Namazi Sq.
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Center, Namazi Hospital, Namazi Sq
City
Shiaz
Postal code
71937 11351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)