Magnesium Sulfate, Thromboelastometry
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGMagnesium 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.
OTHERPlacebo 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.
Sponsors
Aretaieion University Hospital
Marianna Mavromati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Patients are divided into two groups, with one group receiving magnesium sulfate and the other receiving normal saline.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ASA I and II patients * 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
* ASA ≥ III * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clotting Time [CT] (in seconds, measured using ROTEM) | 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) | 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 |
| Clot Formation Time [CFT] (in seconds, measured using ROTEM) | 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 \[CFT\] 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 |
| Maximum Clot Firmness [MCF] (in mm, measured using ROTEM) | 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 \[MCF\] 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 |
| a-angle (in degrees, measured using ROTEM) | 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in PT Before and After Magnesium Administration | 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 will be assessed before and after magnesium administration using a hematology analyzer |
| Changes in Platelet Count Before and After Magnesium Administration | 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 will be assessed before and after magnesium administration using a hematology analyzer |
| Train of Four (TOF) | 4 minutes (time point 0 will be at neuromuscular blocking agent administration) | 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 |
| Clinical thrombosis symptoms | 24 hours (first assessment will be performed immediately before surgery, and the final assessment will be performed 24 hours postoperatively) | Symptoms of clinical thrombosis (e.g., redness, swelling, pain) will be assessed through physical examination by the attending physician before and after magnesium administration |
| Changes in Fibrinogen Levels Before and After Magnesium Administration | 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 will be assessed before and after magnesium administration using the Clauss method |
| Area Under the Curve (AUC) for Nociception Index Level (NOL) | Intraoperative | 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. |
| Changes in INR Before and After Magnesium Administration | 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 INR (International Normalized Ratio) will be assessed before and after magnesium administration using an automated coagulation analysis system |
| Changes in aPTT Before and After Magnesium Administration | 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 will be assessed before and after magnesium administration using an automated coagulation analysis system |
Countries
Greece
Contacts
Primary ContactMarianna Mavromati, MD
Backup ContactKassiani Theodoraki, Professor
Outcome results
None listed