Effect of Magnesium Sulphate on Coagulation

August 22, 2013 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

Effect of Magnesium Sulphate on Postoperative Coagulation as Measured by Thromboelastography

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thromboelastography (TEG) analysis
Time Frame: twice
  1. 10 minutes before the induction of anesthesia
  2. 10 minutes after the recovery from the anesthesia
twice

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin level
Time Frame: twice
  1. 10 minutes before the induction of anesthesia
  2. 10 minutes after the recovery from the anesthesia
twice
platelet count
Time Frame: twice
  1. 10 minutes before the induction of anesthesia
  2. 10 minutes after the recovery from the anesthesia
twice
international normalized ratio of prothrombin time (INR-PT)
Time Frame: twice
  1. 10 minutes before the induction of anesthesia
  2. 10 minutes after the recovery from the anesthesia
twice
activated partial thromboplastin time (aPTT)
Time Frame: tiwce
  1. 10 minutes before the induction of anesthesia
  2. 10 minutes after the recovery from the anesthesia
tiwce
serum magnesium level
Time Frame: twice
  1. 10 minutes before the induction of anesthesia
  2. 10 minutes after the recovery from the anesthesia
twice

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

December 10, 2009

First Submitted That Met QC Criteria

December 14, 2009

First Posted (ESTIMATE)

December 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEG/Mg

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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