Dexmedetomidine and Blood Coagulation

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 12, 2020

Interventions

  • Drug: 0 ul of dexmedetomidine
    • Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0, 0.25, 0.5, and 0.75 ul) using dexmedetomidine
  • Drug: 0.25 ul of dexmedetomidine
    • Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0, 0.25, 0.5, and 0.75 ul) using dexmedetomidine
  • Drug: 0.5 ul of dexmedetomidine
    • Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0, 0.25, 0.5, and 0.75 ul) using dexmedetomidine
  • Drug: 0.75 ul of dexmedetomidine
    • Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0, 0.25, 0.5, and 0.75 ul) using dexmedetomidine

Arms, Groups and Cohorts

  • 0 ng/ml
    • Blood specimen which was added 0 ul of dexmedetomidine
  • 0.5 ng/ml
    • Blood specimen which was added 0.25 ul of dexmedetomidine
  • 1.0 ng/ml
    • Blood specimen which was added 0.5 ul of dexmedetomidine
  • 1.5 ng/ml
    • Blood specimen which was added 0.75 ul of dexmedetomidine

Clinical Trial Outcome Measures

Primary Measures

  • FIBTEM
    • Time Frame: During the rotational thromboelastometry analysis/ an average of 1 hour
    • Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.

Secondary Measures

  • INTEM
    • Time Frame: During the rotational thromboelastometry analysis/ an average of 1 hour
    • Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym.
  • EXTEM
    • Time Frame: During the rotational thromboelastometry analysis/ an average of 1 hour
    • Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym.

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy volunteers
  • Age: 20 to 65 years
  • Body weight > 50 kg
  • Volunteers who provided informed consent

Exclusion Criteria

  • Hematologic disease
  • Anticoagulant medication

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hyo-Seok Na, Associate Professor – Seoul National University Bundang Hospital
  • Overall Official(s)
    • Hyo-Seok Na, MD., PhD., Principal Investigator, Seoul National University Bundang Hospital
  • Overall Contact(s)
    • Hyo-Seok Na, MD., PhD., +82-31-787-7507, hsknana@gmail.com

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