Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Magnesium Sulfate; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patients undergoing a laparoscopic colorectal cancer surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnesium; 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
Placebo Comparator: Control; administration of normal saline as a same volume of magnesium sulphate as a same method.	Drug: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: August 30, 2013
• First Submitted That Met QC Criteria: September 4, 2013
• First Posted (Estimate): September 10, 2013

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: Mg-ROTEM-colorectal ca