Actively Recruiting
Effect of Magnesium Sulfate on Postoperative Hypercoagulability Using Thromboelastometry in Laparoscopic Gynecological Surgeries
Led by Marianna Mavromati · Updated on 2024-12-05
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Marianna Mavromati
Lead Sponsor
A
Aretaieion University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of magnesium sulfate on postoperative hypercoagulability in patients undergoing laparoscopic gynecological surgeries under general anesthesia. This randomized, double-blind, controlled study aims to assess how magnesium sulfate influences blood clotting using thromboelastometry, a method that measures clotting time and clot formation parameters. The study compares magnesium sulfate with a placebo to understand its potential impact on postoperative blood coagulation. Participants are randomly assigned to one of two groups. One group receives an intravenous bolus of magnesium sulfate followed by a continuous infusion during surgery. The other group receives an equivalent volume of normal saline as a placebo. Blood coagulation parameters are measured before and after magnesium sulfate or placebo administration using thromboelastometry, with assessments done intraoperatively and in the post-anesthesia care unit. During the study, patients undergo blood coagulation tests including clotting time, clot formation time, maximum clot firmness, and a-angle measurements. Additional monitoring includes assessments of coagulation markers such as INR, aPTT, PT, platelet count, and fibrinogen levels before surgery and up to six hours afterward. Clinical thrombosis symptoms are also observed for 24 hours after surgery. The study plans to track these measures closely to evaluate the effects of magnesium sulfate on postoperative blood clotting.
CONDITIONS
Brief Title
Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA I and II patients
- Undergoing laparoscopic gynecological surgeries
- Age greater than 18 years
- Receiving prophylactic anticoagulant therapy 12 hours before surgery based on the Caprini score
- Receiving prophylactic anticoagulant therapy 12 hours postoperatively based on the Caprini score
You will not qualify if you...
- ASA III or higher
- Age less than 18 years
- Body mass index over 40 kg/m²
- Pregnancy
- Known hematologic disorders
- Liver, kidney, or cardiovascular disease
- Severe anemia with hemoglobin between 6.5 and 7.9 g/dl
- Inability or refusal to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 hours
Participants receive either magnesium sulfate or a placebo intravenously during laparoscopic gynecological surgery under general anesthesia. Blood coagulation parameters are assessed before and after administration using thromboelastometry.
1 intraoperative visit and 1 post-anesthesia care unit visit
Duration - 24 hours
Participants are monitored for clinical thrombosis symptoms and coagulation changes up to 24 hours after surgery.
1 visit 24 hours postoperatively
Trial Site Locations
Total: 1 location
1
Aretaieion University Hospital
Athens, Attica, Greece, 11528
Actively Recruiting
Research Team
M
Marianna Mavromati, MD
K
Kassiani Theodoraki, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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