Magnesium SulfateNCT06717490
Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries
A study testing Magnesium sulphate in people with Magnesium Sulfate and Thromboelastometry, run by Marianna Mavromati at 1 site in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Magnesium Sulfate, Thromboelastometry
- What is being tested?
- Magnesium sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Aretaieion University Hospital
Athens, Attica, 11528
Marianna Mavromati, MD, 00306975630647, marimavr14@gmail.com
Marianna Mavromati, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Magnesium Sulfate, Thromboelastometry
- Being tested
- Magnesium sulphate, Placebo Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulphateDrug
Also called Thromboelastometry
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 DrugOther
Also called Thromboelastometry
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
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
Measured: 4 minutes (time point 0 will be at neuromuscular blocking agent administration)
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.
Measured: Intraoperative
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
Measured: 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
Changes in aPTT will be assessed before and after magnesium administration using an automated coagulation analysis system
Measured: 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
Changes in platelet count will be assessed before and after magnesium administration using a hematology analyzer
Measured: 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
Changes in platelet count will be assessed before and after magnesium administration using a hematology analyzer
Measured: 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
Changes in fibrinogen levels will be assessed before and after magnesium administration using the Clauss method
Measured: 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
Symptoms of clinical thrombosis (e.g., redness, swelling, pain) will be assessed through physical examination by the attending physician before and after magnesium administration
Measured: 24 hours (first assessment will be performed immediately before surgery, and the final assessment will be performed 24 hours postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnesium SulfateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are divided into two groups, with one group receiving magnesium sulfate and the other receiving normal saline.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marianna Mavromati
- Sponsor type
- University, hospital or other
- Collaborators
- Aretaieion University Hospital
- Responsible party
- Sponsor-investigator, Marianna Mavromati, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, Professor, Study chair, Aretaieio University Hospital, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717490
- Sponsor's protocol ID
- 619/05-11-2024
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulfate on Postoperative Hypercoagulability Using Thromboelastometry in Laparoscopic Gynecological Surgeries
- ClinicalTrials.gov ID
- NCT06717490
- Acronym / sponsor ID
- 619/05-11-2024
- Conditions
- Magnesium Sulfate, Thromboelastometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marianna MavromatiUniversity, hospital or other
- Collaborators
- Aretaieion University Hospital
- Study start
- Dec 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients are divided into two groups, with one group receiving magnesium sulfate and the other receiving normal saline.
| Arm | Type | Receives |
|---|---|---|
| MS group | Active comparator | Drug: Magnesium sulphateThe 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. |
| NS group | Placebo comparator | Other: Placebo DrugThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- ASA ≥ III
- age <18 years
- BMI >40 kg/m²
- Pregnancy
- Known hematologic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulphateAlso: ThromboelastometryIn 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. | Drug | MS group |
| Placebo DrugAlso: ThromboelastometryIn 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 | NS group |
Primary outcome
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
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
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
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
8 secondary outcomes
Train of Four (TOF)
Time frame: 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
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 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 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 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 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kassiani Theodoraki, Professor study chair
Aretaieio University Hospital, National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulphate in people with Magnesium Sulfate and Thromboelastometry, run by Marianna Mavromati at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianna Mavromati, MD (0030 6975630647, marimavr14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.