Effect of Magnesium Sulfate on Postoperative Hypercoagulability Using Thromboelastometry in Laparoscopic Gynecological Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clotting Time [CT] (in seconds, measured using ROTEM)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Magnesium sulphate (Drug)
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.
干预措施: Placebo Drug (Other)
结局指标
主要结局
Clotting Time [CT] (in seconds, measured using ROTEM)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- Train of Four (TOF)(4 minutes (time point 0 will be at neuromuscular blocking agent administration))
- Area Under the Curve (AUC) for Nociception Index Level (NOL)(Intraoperative)
- 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 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 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 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 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))
- Clinical thrombosis symptoms(24 hours (first assessment will be performed immediately before surgery, and the final assessment will be performed 24 hours postoperatively))
研究者
Marianna Mavromati
Marianna Mavromati, MD, Principal Investigator and Anesthesiology Resident, Aretaieion University Hospital, NKUA
Aretaieion University Hospital