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| Name | Class |
|---|---|
| Aretaieion University Hospital | OTHER |
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This will be a prospective randomized, double-blind study, aiming at investigating the effects of magnesium sulfate on postoperative hypercoagulability in patients undergoing laparoscopic gynecological surgeries under general anesthesia
This randomized, double-blind, controlled study investigates the effects of magnesium sulfate on postoperative hypercoagulability in patients undergoing laparoscopic gynecological surgeries under general anesthesia. Using thromboelastometry, the study aims to assess the impact of magnesium sulfate on blood coagulation parameters. Patients are divided into two groups, with one group receiving magnesium sulfate and the other receiving normal saline. Both patients and investigators are blinded to the treatment allocation. The study will analyze clotting time, clot formation, and coagulation markers to evaluate the therapeutic potential of magnesium sulfate in reducing postoperative hypercoagulability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS group | Active Comparator | 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. |
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| NS group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulphate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clotting Time [CT] (in seconds, measured using ROTEM) | Clotting Time [CT] is measured using Thromboelastometry (ROTEM) as part of coagulation parameters. CT represents the time (in seconds) required for the initial clot formation in the blood sample | Up to six hours (first thromboelastometry will be performed immediately before magnesium administration intraoperatively, and the second thromboelastometry will be performed at the post-anesthesia care unit) |
| Clot Formation Time [CFT] (in seconds, measured using ROTEM) | Clot Formation Time [CFT] is measured using Thromboelastometry (ROTEM) to evaluate the time required for the clot to stabilize. CFT is expressed in seconds and represents the time to achieve adequate clot firmness in the blood sample | Up to six hours (first thromboelastometry will be performed immediately before magnesium administration intraoperatively, and the second thromboelastometry will be performed at the post-anesthesia care unit) |
| Maximum Clot Firmness [MCF] (in mm, measured using ROTEM) | Maximum Clot Firmness [MCF] is measured using Thromboelastometry (ROTEM) to evaluate the maximum stability of the clot. MCF is expressed in millimeters and represents the highest clot firmness achieved in the blood sample | Up to six hours (first thromboelastometry will be performed immediately before magnesium administration intraoperatively, and the second thromboelastometry will be performed at the post-anesthesia care unit) |
| a-angle (in degrees, measured using ROTEM) | a-angle measured using Thromboelastometry (ROTEM) to assess the rate of fibrin polymerization and clot formation dynamics. The a-angle is expressed in degrees (°) and indicates the speed of fibrin build-up | Up to six hours (first thromboelastometry will be performed immediately before magnesium administration intraoperatively, and the second thromboelastometry will be performed at the post-anesthesia care unit) |
| Measure | Description | Time Frame |
|---|---|---|
| Train of Four (TOF) | Train of Four (TOF) will be measured using a neuromuscular stimulator to assess neuromuscular blockade. Measurements will be noted at the induction of general anesthesia after neuromuscular blocking agent administration until TOF reaches zero | 4 minutes (time point 0 will be at neuromuscular blocking agent administration) |
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Inclusion Criteria:
Exclusion Criteria:
Eligible participants include individuals with biologically female internal reproductive organs (e.g., XX chromosomes and uterus), regardless of their self-identified gender.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marianna Mavromati, MD | Contact | 0030 6975630647 | marimavr14@gmail.com | |
| Kassiani Theodoraki, Professor | Contact | 00306974634162 | ktheodoraki@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kassiani Theodoraki, Professor | Aretaieio University Hospital, National and Kapodistrian University of Athens | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aretaieion University Hospital | Recruiting | Athens | Attica | 11528 | Greece |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D013916 | Thrombelastography |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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Patients are divided into two groups, with one group receiving magnesium sulfate and the other receiving normal saline.
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| Placebo Drug | Other | 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. |
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| Area Under the Curve (AUC) for Nociception Index Level (NOL) | Nociception Index Level (NOL) will be measured using the NOL monitoring system. Measurements will be performed throughout the surgery, and the area under the curve (AUC) will be calculated to evaluate nociceptive responses. | Intraoperative |
| Changes in INR Before and After Magnesium Administration | Changes in INR (International Normalized Ratio) will be assessed before and after magnesium administration using an automated coagulation analysis system | Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit) |
| Changes in aPTT Before and After Magnesium Administration | Changes in aPTT will be assessed before and after magnesium administration using an automated coagulation analysis system | Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit) |
| Changes in PT Before and After Magnesium Administration | Changes in platelet count will be assessed before and after magnesium administration using a hematology analyzer | Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit) |
| Changes in Platelet Count Before and After Magnesium Administration | Changes in platelet count will be assessed before and after magnesium administration using a hematology analyzer | Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit) |
| Changes in Fibrinogen Levels Before and After Magnesium Administration | Changes in fibrinogen levels will be assessed before and after magnesium administration using the Clauss method | Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit) |
| Clinical thrombosis symptoms | Symptoms of clinical thrombosis (e.g., redness, swelling, pain) will be assessed through physical examination by the attending physician before and after magnesium administration | 24 hours (first assessment will be performed immediately before surgery, and the final assessment will be performed 24 hours postoperatively) |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |