Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

Study Overview
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Brief Summary
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Magnesium sulphate is given to the patients during the colorectal cancer surgery under the hypothesis that it would attenuate the postoperative hypercoagulability. The investigators intend to characterize the changes of coagulation in colorectal cancer patients by using the point-of-care device after the infusion of magnesium sulphate.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients undergoing a laparoscopic colorectal cancer surgery Exclusion Criteria: Renal disease Hepatic disease Neuromuscular disease Coagulation disorder Cardiopulmonary disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium<br>Magnesium sulfate infusion during a operation period. Infusion regimen: Bolus 50 mg/kg of magnesium sulfate in 100 ml normal saline over 15 minutes Infusion 15 mg/kg/h of magnesium sulfate throughout the operation | Drug: Magnesium Sulfate<br> <br> |
| Placebo Comparator: Control<br>administration of normal saline as a same volume of magnesium sulphate as a same method. | Drug: Normal saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of maximum clot firmness (MCF) of FIBTEM |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of Clotting time (CT) of INTEM |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of Clot firmness time (CFT) of INTEM |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of Alpha angle of INTEM |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of MCF of INTEM |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of CT of EXTEM |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of CFT of EXTEM |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of Alpha angle of EXTEM |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of MCF of EXTEM |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Hemoglobin |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of Platelet count |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of International normalized ratio of prothrombin time |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of Activated partial thrombin time |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day | 
| Change of Fibrinogen |  | 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day |