Dexmedetomidine and Blood Coagulation

Blood Coagulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04269278
• Other study ID #: B-2002/595-301
• Status: Completed
• Start date: February 12, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Age: 20 to 65 years

• Body weight > 50 kg

• Volunteers who provided informed consent

Exclusion Criteria:

• Hematologic disease

• Anticoagulant medication

Related Conditions & MeSH terms

• Blood Coagulation Disorder
• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

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 ul) using dexmedetomidine
• 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 (0.25 ul) using dexmedetomidine
• 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 (0.5 ul) using dexmedetomidine
• 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 (0.75 ul) using dexmedetomidine

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIBTEM	Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.	During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary	INTEM	Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym.	During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary	EXTEM	Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym.	During the rotational thromboelastometry analysis/ an average of 1 hour