Dexmedetomidine and Blood Coagulation

Study Overview
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Brief Summary
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Dexmedetomidine may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of dexmedetomidine. The investigators have therefore performed the present study to measure the effect of dexmedetomidine on the coagulation pathway according to the drug concentration level using a rotational thromboelastometry test.

Official Title
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The Effect of Dexmedetomidine on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry

Conditions
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Blood Coagulation Disorder

Intervention / Treatment
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* Drug: 0 ul of dexmedetomidine
* Drug: 0.25 ul of dexmedetomidine
* Drug: 0.5 ul of dexmedetomidine
* Drug: 0.75 ul of dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Age: 20 to 65 years Body weight > 50 kg Volunteers who provided informed consent Exclusion Criteria: Hematologic disease Anticoagulant medication

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 0 ng/ml<br>Blood specimen which was added 0 ul of dexmedetomidine | Drug: 0 ul of dexmedetomidine<br>* Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using dexmedetomidine<br>|
| 0.5 ng/ml<br>Blood specimen which was added 0.25 ul of dexmedetomidine | Drug: 0.25 ul of dexmedetomidine<br>* Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.25 ul) using dexmedetomidine<br>|
| 1.0 ng/ml<br>Blood specimen which was added 0.5 ul of dexmedetomidine | Drug: 0.5 ul of dexmedetomidine<br>* Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.5 ul) using dexmedetomidine<br>|
| 1.5 ng/ml<br>Blood specimen which was added 0.75 ul of dexmedetomidine | Drug: 0.75 ul of dexmedetomidine<br>* Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.75 ul) using dexmedetomidine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIBTEM | Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym. | During the rotational thromboelastometry analysis/ an average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INTEM | Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym. | During the rotational thromboelastometry analysis/ an average of 1 hour | 
| EXTEM | Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym. | During the rotational thromboelastometry analysis/ an average of 1 hour |