Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Normal saline; Drug: Magnesium Sulfate

• Registration Number: NCT01938300
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2013-08-30
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• The patients undergoing a laparoscopic colorectal cancer surgery

Exclusion Criteria

• Renal disease
• Hepatic disease
• Neuromuscular disease
• Coagulation disorder
• Cardiopulmonary disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	administration of normal saline as a same volume of magnesium sulphate as a same method.
Magnesium	Magnesium Sulfate	Magnesium sulfate infusion during a operation period. Infusion regimen: 1. Bolus 50 mg/kg of magnesium sulfate in 100 ml normal saline over 15 minutes 2. Infusion 15 mg/kg/h of magnesium sulfate throughout the operation

Primary Outcome Measures

Name	Time	Method
Change of Alpha angle of EXTEM	1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day
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 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 Clotting time (CT) 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 CFT 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
Change of CT of EXTEM	1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of