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Completed

NCT Number: NCT01032213

Effect of Magnesium Sulphate on Coagulation

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).

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Key information

Conditions

Myoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

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

normal saline

Drug

Group S received the same volume of isotonic saline as same method.

Other names: isotonic saline

Primary outcomes

  1. thromboelastography (TEG) analysis

    Time frame: twice

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

Secondary outcomes

  1. hemoglobin level

    Time frame: twice

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

  2. platelet count

    Time frame: 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)

    Time frame: twice

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

  4. activated partial thromboplastin time (aPTT)

    Time frame: tiwce

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

  5. serum magnesium level

    Time frame: twice

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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Effect of Magnesium Sulphate on Postoperative Coagulation as Measured by Thromboelastography

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 15, 2009
Registry last updated
Aug 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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