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Completed

NCT Number: NCT04269278

Dexmedetomidine and Blood Coagulation

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.

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Key information

Conditions

Blood Coagulation Disorder Blood Coagulation Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Hematologic disease
  • Anticoagulant medication

Treatment and study plan

0 ul of dexmedetomidine

Drug

Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using dexmedetomidine

0.25 ul of dexmedetomidine

Drug

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

0.5 ul of dexmedetomidine

Drug

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

0.75 ul of dexmedetomidine

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 13, 2020
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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