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Effect of Magnesium Sulphate on Coagulation

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01032213
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
9
Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Arterial and venous thrombotic events are the clinical manifestation of postoperative hypercoagulability. Altered serum magnesium may play a role in the balance of coagulation. In this study, the investigators investigated the effect of magnesium sulphate on the postoperative coagulation change in total intravenous anesthesia (TIVA).

Condition or Disease Intervention/Treatment Phase
  • Drug: Magnesium Sulfate
  • Drug: normal saline
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Magnesium Sulphate on Postoperative Coagulation as Measured by Thromboelastography
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: group C

control group

Drug: normal saline
Group S received the same volume of isotonic saline as same method.
Other Names:
  • isotonic saline

    		•
    Experimental: group M

    magnesium group

    Drug: Magnesium Sulfate
    Group M received 50 mg/kg of magnesium sulphate on 100 ml of isotonic saline over 10 minutes during the anesthesia induction, followed by the 15 mg/kg/h by continuous infusion during the operation
    Other Names:
  • magnesium sulphate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. thromboelastography (TEG) analysis [twice]

      10 minutes before the induction of anesthesia 10 minutes after the recovery from the anesthesia

    Secondary Outcome Measures

    1. hemoglobin level [twice]

      10 minutes before the induction of anesthesia 10 minutes after the recovery from the anesthesia

    2. platelet count [twice]

      10 minutes before the induction of anesthesia 10 minutes after the recovery from the anesthesia

    3. international normalized ratio of prothrombin time (INR-PT) [twice]

      10 minutes before the induction of anesthesia 10 minutes after the recovery from the anesthesia

    4. activated partial thromboplastin time (aPTT) [tiwce]

      10 minutes before the induction of anesthesia 10 minutes after the recovery from the anesthesia

    5. serum magnesium level [twice]

      10 minutes before the induction of anesthesia 10 minutes after the recovery from the anesthesia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ASA Ⅰ-Ⅱ patients undergoing pelviscopic gynecologic operation under general anesthesia.
    Exclusion Criteria:

    • Pregnancy

    • Previous known hematologic disorder

    • Recent medication interfering with hemostasis

    • Severe anemia

    • Liver disease

    • Cardiovascular or respiratory disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 463-707

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hyo-Seok Na, Dr., Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT01032213
    Other Study ID Numbers:
    • TEG/Mg
    First Posted:
    Dec 15, 2009
    Last Update Posted:
    Aug 26, 2013
    Last Verified:
    Aug 1, 2013
    Additional relevant MeSH terms:
    Magnesium Sulfate

    Study Results

    No Results Posted as of Aug 26, 2013