Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries
NCT ID: NCT06717490
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-12-31
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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MS group
The patients allocated to this group will receive an intravenous bolus of magnesium sulfate (50 mg/kg) followed by a continuous infusion (15 mg/kg/h) Blood coagulation parameters will be assessed pre- and post- magnesium administration using thromboelastometry.
Magnesium sulphate
In patients allocated to the MS group, a fixed dose of magnesium sulfate diluted in a fixed volume of natural saline will be administered intravenously.
Thromboelastometry will be performed pre and post magnesium administration.
NS group
The patients allocated to this group will receive an equivalent volume of normal saline proportionally to the active comparator group. Blood coagulation parameters will be assessed pre- and post-magnesium administration using thromboelastometry.
Placebo Drug
In patients allocated to the NS group, a fixed dose of natural saline will be administered intravenously, through a fixed volume of solution.
Thromboelastometry will be performed pre and post magnesium administration.
Interventions
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Magnesium sulphate
In patients allocated to the MS group, a fixed dose of magnesium sulfate diluted in a fixed volume of natural saline will be administered intravenously.
Thromboelastometry will be performed pre and post magnesium administration.
Placebo Drug
In patients allocated to the NS group, a fixed dose of natural saline will be administered intravenously, through a fixed volume of solution.
Thromboelastometry will be performed pre and post magnesium administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Laparoscopic gynecological surgeries
* age \>18 years
* Patients receiving prophylactic anticoagulant therapy 12 hours before surgery based on the Caprini score
* Patients receiving prophylactic anticoagulant therapy 12 hours postoperatively based on the Caprini score.
Exclusion Criteria
* age \<18 years
* BMI \>40 kg/m²
* Pregnancy
* Known hematologic disorders
* Liver/kidney/cardiovascular disease
* Severe anemia (6,5- 7,9 g/dl)
* Inability or refusal to provide informed consent
18 Years
FEMALE
Yes
Sponsors
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Aretaieion University Hospital
OTHER
Marianna Mavromati
OTHER
Responsible Party
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Marianna Mavromati
Marianna Mavromati, MD, Principal Investigator and Anesthesiology Resident, Aretaieion University Hospital, NKUA
Principal Investigators
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Kassiani Theodoraki, Professor
Role: STUDY_CHAIR
Aretaieio University Hospital, National and Kapodistrian University of Athens
Locations
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Aretaieion University Hospital
Athens, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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Marianna Mavromati, MD
Role: primary
Marianna Mavromati, MD
Role: backup
Other Identifiers
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619/05-11-2024
Identifier Type: -
Identifier Source: org_study_id