Effect of Magnesium Sulphate on Coagulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01032213
First received: December 10, 2009
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 Intervention
Myoma
Drug: Magnesium Sulfate
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Magnesium Sulphate on Postoperative Coagulation as Measured by Thromboelastography

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • thromboelastography (TEG) analysis [ Time Frame: twice ] [ Designated as safety issue: No ]
    1. 10 minutes before the induction of anesthesia
    2. 10 minutes after the recovery from the anesthesia


Secondary Outcome Measures:
  • hemoglobin level [ Time Frame: twice ] [ Designated as safety issue: No ]
    1. 10 minutes before the induction of anesthesia
    2. 10 minutes after the recovery from the anesthesia

  • platelet count [ Time Frame: twice ] [ Designated as safety issue: No ]
    1. 10 minutes before the induction of anesthesia
    2. 10 minutes after the recovery from the anesthesia

  • international normalized ratio of prothrombin time (INR-PT) [ Time Frame: twice ] [ Designated as safety issue: No ]
    1. 10 minutes before the induction of anesthesia
    2. 10 minutes after the recovery from the anesthesia

  • activated partial thromboplastin time (aPTT) [ Time Frame: tiwce ] [ Designated as safety issue: No ]
    1. 10 minutes before the induction of anesthesia
    2. 10 minutes after the recovery from the anesthesia

  • serum magnesium level [ Time Frame: twice ] [ Designated as safety issue: No ]
    1. 10 minutes before the induction of anesthesia
    2. 10 minutes after the recovery from the anesthesia


Enrollment: 40
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: group C
control group
Drug: normal saline
Group S received the same volume of isotonic saline as same method.
Other Name: 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 Name: magnesium sulphate

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01032213

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

No publications provided

Responsible Party: Hyo-Seok Na, Dr., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01032213     History of Changes
Other Study ID Numbers: TEG/Mg
Study First Received: December 10, 2009
Last Updated: August 22, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Myoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 28, 2014