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CompletedNCT01938300Updated Nov 20, 2015

Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

An interventional study of Magnesium Sulfate and Normal saline in Colorectal Cancer, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-11-20.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 44 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The patients undergoing a laparoscopic colorectal cancer surgery

Exclusion criteria

Exclusion Criteria:

  • Renal disease
  • Hepatic disease
  • Neuromuscular disease
  • Coagulation disorder
  • Cardiopulmonary disease
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • 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

Interventions

  • DrugMagnesium Sulfate
  • DrugNormal saline
06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi 463-707, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01938300
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Hyo-Seok Na (Dr., Seoul National University Bundang Hospital) — Principal investigator
First posted
Sep 10, 2013
Start date
Jun 2011
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Nov 20, 2015
View the source record on ClinicalTrials.gov ↗

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