Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries

Marianna Mavromati

Status: Enrolling

Conditions: Magnesium Sulfate; Thromboelastometry

Treatments: Other: Placebo Drug; Drug: Magnesium sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT06717490

619/05-11-2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

MS group

Active Comparator group

Description:

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.

Treatment:

Drug: Magnesium sulphate

NS group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Drug