Effect of Magnesium Sulphate on Coagulation

Myoma Clinical Trial

Official title:

Effect of Magnesium Sulphate on Postoperative Coagulation as Measured by Thromboelastography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032213
• Other study ID #: TEG/Mg
• Status: Completed
• Phase: N/A
• First received: December 10, 2009
• Last updated: August 22, 2013
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: August 2013
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA ?-? 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thromboelastography (TEG) analysis	10 minutes before the induction of anesthesia; 10 minutes after the recovery from the anesthesia	twice	No
Secondary	hemoglobin level	10 minutes before the induction of anesthesia; 10 minutes after the recovery from the anesthesia	twice	No
Secondary	platelet count	10 minutes before the induction of anesthesia; 10 minutes after the recovery from the anesthesia	twice	No
Secondary	international normalized ratio of prothrombin time (INR-PT)	10 minutes before the induction of anesthesia; 10 minutes after the recovery from the anesthesia	twice	No
Secondary	activated partial thromboplastin time (aPTT)	10 minutes before the induction of anesthesia; 10 minutes after the recovery from the anesthesia	tiwce	No
Secondary	serum magnesium level	10 minutes before the induction of anesthesia; 10 minutes after the recovery from the anesthesia	twice	No