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Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

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ClinicalTrials.gov Identifier: NCT01938300
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Magnesium Sulfate Drug: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : June 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Magnesium

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
Drug: Magnesium Sulfate
Placebo Comparator: Control
administration of normal saline as a same volume of magnesium sulphate as a same method.
Drug: Normal saline



Primary Outcome Measures :
  1. Change of maximum clot firmness (MCF) of FIBTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  2. Change of Clotting time (CT) of INTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  3. Change of Clot firmness time (CFT) of INTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  4. Change of Alpha angle of INTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  5. Change of MCF of INTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  6. Change of CT of EXTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  7. Change of CFT of EXTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  8. Change of Alpha angle of EXTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  9. Change of MCF of EXTEM [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]

Secondary Outcome Measures :
  1. Change of Hemoglobin [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  2. Change of Platelet count [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  3. Change of International normalized ratio of prothrombin time [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  4. Change of Activated partial thrombin time [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]
  5. Change of Fibrinogen [ Time Frame: 1 day before a operation, 1 hour after finishing a operation, and a postopearative 3 day ]


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients undergoing a laparoscopic colorectal cancer surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938300


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital

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Responsible Party: Hyo-Seok Na, Dr., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01938300     History of Changes
Other Study ID Numbers: Mg-ROTEM-colorectal ca
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2013
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents