Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06717490

Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Magnesium Sulfate Thromboelastometry

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aretaieion University Hospital

Athens, Attica, 11528, Greece

Location status: Recruiting

Location contact

Marianna Mavromati, MD

CONTACT

[email protected]

00306975630647

Marianna Mavromati, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Thromboelastometry

Placebo drug

Other

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.

Other names: Thromboelastometry

Primary outcomes

  1. 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)

    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

  2. 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)

    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

  3. 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)

    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

  4. 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)

    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

Secondary outcomes

  1. Train of Four (TOF)

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

    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

  2. Area Under the Curve (AUC) for Nociception Index Level (NOL)

    Time frame: Intraoperative

    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.

  3. 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 INR (International Normalized Ratio) will be assessed before and after magnesium administration using an automated coagulation analysis system

  4. 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 aPTT will be assessed before and after magnesium administration using an automated coagulation analysis system

  5. 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 will be assessed before and after magnesium administration using a hematology analyzer

  6. 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 platelet count will be assessed before and after magnesium administration using a hematology analyzer

  7. 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)

    Changes in fibrinogen levels will be assessed before and after magnesium administration using the Clauss method

  8. 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)

    Symptoms of clinical thrombosis (e.g., redness, swelling, pain) will be assessed through physical examination by the attending physician before and after magnesium administration

Study contacts

Contact information is provided by the study sponsor or research team.

Kassiani Theodoraki, Professor

CONTACT

[email protected]

00306974634162

Marianna Mavromati, MD

CONTACT

[email protected]

0030 6975630647

Sponsors and collaborators

Lead sponsor

Marianna Mavromati

Other

Collaborators

  • Aretaieion University Hospital

Registry information

Official study title

Effect of Magnesium Sulfate on Postoperative Hypercoagulability Using Thromboelastometry in Laparoscopic Gynecological Surgeries

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.