Clinical trial NCT06717490: Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries
Official title: Effect of Magnesium Sulfate on Postoperative Hypercoagulability Using Thromboelastometry in Laparoscopic Gynecological Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Magnesium Sulfate
Thromboelastometry
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
Collaborators: name: Aretaieion University Hospital
First posted: 2024-12-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are divided into two groups, with one group receiving magnesium sulfate and the other receiving normal saline.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Clotting Time [CT] (in seconds, measured using ROTEM)
timeFrame: 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: Clot Formation Time [CFT] (in seconds, measured using ROTEM)
timeFrame: 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: Maximum Clot Firmness [MCF] (in mm, measured using ROTEM)
timeFrame: 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: a-angle (in degrees, measured using ROTEM)
timeFrame: 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 outcomes:
measure: Train of Four (TOF)
timeFrame: 4 minutes (time point 0 will be at neuromuscular blocking agent administration)
measure: Area Under the Curve (AUC) for Nociception Index Level (NOL)
timeFrame: Intraoperative
measure: Changes in INR Before and After Magnesium Administration
timeFrame: Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)
measure: Changes in aPTT Before and After Magnesium Administration
timeFrame: Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)
measure: Changes in PT Before and After Magnesium Administration
timeFrame: Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)
measure: Changes in Platelet Count Before and After Magnesium Administration
timeFrame: Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)
measure: Changes in Fibrinogen Levels Before and After Magnesium Administration
timeFrame: Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)
measure: Clinical thrombosis symptoms
timeFrame: 24 hours (first assessment will be performed immediately before surgery, and the final assessment will be performed 24 hours postoperatively)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
state: Attica
Study officials:
affiliation: Aretaieio University Hospital, National and Kapodistrian University of Athens
name: Kassiani Theodoraki, Professor
role: STUDY_CHAIR
References: