Effect of Magnesium Sulphate on Coagulation

NCT01032213 | Completed DMC

• 1 other identifier: TEG/Mg
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Myoma

Outcome Measures

Primary Outcomes (1)

• thromboelastography (TEG) analysis

  1. 10 minutes before the induction of anesthesia 2. 10 minutes after the recovery from the anesthesia

  twice

Secondary Outcomes (5)

• hemoglobin level

  twice

• platelet count

  twice

• international normalized ratio of prothrombin time (INR-PT)

  twice

• activated partial thromboplastin time (aPTT)

  tiwce

• serum magnesium level

  twice

Study Arms (2)

group C

PLACEBO COMPARATOR

control group

Drug: normal saline

group M

EXPERIMENTAL

magnesium group

Drug: Magnesium Sulfate

Interventions

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

Also known as: magnesium sulphate

group M

normal saline DRUG

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

Also known as: isotonic saline

group C

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA Ⅰ-Ⅱ patients undergoing pelviscopic gynecologic operation under general anesthesia.

You may not qualify if:

• Pregnancy
• Previous known hematologic disorder
• Recent medication interfering with hemostasis
• Severe anemia
• Liver disease
• Cardiovascular or respiratory disease

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Myoma

Interventions

Magnesium Sulfate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 15, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 26, 2013

Record last verified: 2013-08

Locations

KR (1)