MyomaNCT01032213
Effect of Magnesium Sulphate on Coagulation
A study testing Magnesium Sulfate and normal saline in people with Myoma, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Myoma
- What is being tested?
- Magnesium Sulfate and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA Ⅰ-Ⅱ patients undergoing pelviscopic gynecologic operation under general anesthesia.
Who cannot join
- Pregnancy
- Previous known hematologic disorder
- Recent medication interfering with hemostasis
- Severe anemia
- Liver disease
- Cardiovascular or respiratory disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: 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).
- Conditions
- Myoma
- Being tested
- Magnesium Sulfate, normal saline
- Medical subject headings
- Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Also called magnesium sulphate
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 salineDrug
Also called isotonic saline
Group S received the same volume of isotonic saline as same method.
| Study group | Role | What they receive |
|---|---|---|
| group C | Placebo comparator | control group Receives: Drug: normal saline |
| group M | Experimental | magnesium group Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
thromboelastography (TEG) analysis
- 10 minutes before the induction of anesthesia
- 10 minutes after the recovery from the anesthesia
Measured: twice
Secondary outcomes (5)
hemoglobin level
- 10 minutes before the induction of anesthesia
- 10 minutes after the recovery from the anesthesia
Measured: twice
platelet count
- 10 minutes before the induction of anesthesia
- 10 minutes after the recovery from the anesthesia
Measured: twice
international normalized ratio of prothrombin time (INR-PT)
- 10 minutes before the induction of anesthesia
- 10 minutes after the recovery from the anesthesia
Measured: twice
activated partial thromboplastin time (aPTT)
- 10 minutes before the induction of anesthesia
- 10 minutes after the recovery from the anesthesia
Measured: tiwce
serum magnesium level
- 10 minutes before the induction of anesthesia
- 10 minutes after the recovery from the anesthesia
Measured: twice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032213
- Sponsor's protocol ID
- TEG/Mg
- Status last verified
- Aug 2013
- First submitted
- 10 Dec 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulphate on Postoperative Coagulation as Measured by Thromboelastography
- ClinicalTrials.gov ID
- NCT01032213
- Acronym / sponsor ID
- TEG/Mg
- Conditions
- Myoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group C | Placebo comparator | Drug: normal salinecontrol group |
| group M | Experimental | Drug: Magnesium Sulfatemagnesium group |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA Ⅰ-Ⅱ patients undergoing pelviscopic gynecologic operation under general anesthesia.
Key exclusion criteria (6 listed)
- Pregnancy
- Previous known hematologic disorder
- Recent medication interfering with hemostasis
- Severe anemia
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateAlso: magnesium sulphateGroup 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 | Drug | group M |
| normal salineAlso: isotonic salineGroup S received the same volume of isotonic saline as same method. | Drug | group C |
Primary outcome
thromboelastography (TEG) analysis
Time frame: twice
1. 10 minutes before the induction of anesthesia 2. 10 minutes after the recovery from the anesthesia
5 secondary outcomes
hemoglobin level
Time frame: twice
platelet count
Time frame: twice
international normalized ratio of prothrombin time (INR-PT)
Time frame: twice
activated partial thromboplastin time (aPTT)
Time frame: tiwce
serum magnesium level
Time frame: twice
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate and normal saline in people with Myoma, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thromboelastography (TEG) analysis (time frame: twice). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.