Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries

November 30, 2024 updated by: Marianna Mavromati

Effect of Magnesium Sulfate on Postoperative Hypercoagulability Using Thromboelastometry 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11528
        • Recruiting
        • ARETAIEION University Hospital
        • Contact:
        • Contact:
          • Marianna Mavromati, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Magnesium sulphate

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 Comparator: 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.
Other: Placebo Drug

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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] (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
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] (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
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 (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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 minutes (time point 0 will be at neuromuscular blocking agent administration)
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.
Intraoperative
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
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
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
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
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
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
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
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
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
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
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
24 hours (first assessment will be performed immediately before surgery, and the final assessment will be performed 24 hours postoperatively)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marianna Mavromati

Collaborators

Aretaieion University Hospital

Investigators

  • Study Chair: Kassiani Theodoraki, Professor, Aretaieio University Hospital, National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 30, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

November 30, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 619/05-11-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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