About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

ASA ≥ III

age <18 years

BMI >40 kg/m²

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

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.
Placebo Drug
Other intervention
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: MS groupActive comparator 1 intervention

Group B: NS groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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)

2

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

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)

3

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

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)

4

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

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 outcomes

1

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

Time frame

4 minutes (time point 0 will be at neuromuscular blocking agent administration)

2

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.

Time frame

Intraoperative

3

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

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)

4

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

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)

Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts