Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnesium sulphate, Placebo Drug.
- Who it may be relevant to
- Registry conditions: Magnesium Sulfate, Thromboelastometry. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Magnesium Sulfate on Postoperative Hypercoagulability Using Thromboelastometry in Laparoscopic Gynecological Surgeries
Overview
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
- Drug 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. - Other 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.
Primary outcome measures
- Clotting Time [CT] (in seconds, measured using ROTEM) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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)]
Secondary outcome measures (8)
- Train of Four (TOF) [Time frame: 4 minutes (time point 0 will be at neuromuscular blocking agent administration)]
- Area Under the Curve (AUC) for Nociception Index Level (NOL) [Time frame: Intraoperative]
- Changes in INR Before and After Magnesium Administration [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 24 hours (first assessment will be performed immediately before surgery, and the final assessment will be performed 24 hours postoperatively)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
Greece · 1 center
- Aretaieion University Hospital — Athens
Identifiers
NCT: NCT06717490 · 619/05-11-2024