Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries

NCT06717490 | Recruiting DMC

• 1 other identifier: 619/05-11-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Magnesium Sulfate; Thromboelastometry

Outcome Measures

Primary Outcomes (4)

• 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

  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)

  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)

  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)

  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 Outcomes (8)

• Train of Four (TOF)

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

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

  Intraoperative

• Changes in INR Before and After Magnesium Administration

  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

  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

  Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)

Study Arms (2)

MS group

ACTIVE COMPARATOR

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

NS group

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Thromboelastometry

MS group

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.

Also known as: Thromboelastometry

NS group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible participants include individuals with biologically female internal reproductive organs (e.g., XX chromosomes and uterus), regardless of their self-identified gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marianna Mavromati: lead
• Aretaieion University Hospital: collaborator

Study Sites (1)

Aretaieion University Hospital

Athens, Attica, 11528, Greece

RECRUITING

MeSH Terms

Interventions

Magnesium Sulfate; Thrombelastography

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Kassiani Theodoraki, Professor

  Aretaieio University Hospital, National and Kapodistrian University of Athens

  STUDY CHAIR

Central Study Contacts

Marianna Mavromati, MD

CONTACT

0030 6975630647; marimavr14@gmail.com

Kassiani Theodoraki, Professor

CONTACT

00306974634162; ktheodoraki@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Marianna Mavromati, MD, Principal Investigator and Anesthesiology Resident, Aretaieion University Hospital, NKUA

Model Details: Patients are divided into two groups, with one group receiving magnesium sulfate and the other receiving normal saline.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 5, 2024
• Study Start: December 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)