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

Dexmedetomidine and Blood Coagulation

Sponsors

Lead sponsor: Seoul National University Bundang Hospital

Source Seoul National University Bundang Hospital
Brief 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.

Overall Status Recruiting
Start Date February 12, 2020
Completion Date December 30, 2020
Primary Completion Date December 12, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
FIBTEM During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary Outcome
Measure Time Frame
INTEM During the rotational thromboelastometry analysis/ an average of 1 hour
EXTEM During the rotational thromboelastometry analysis/ an average of 1 hour
Enrollment 11
Condition
Intervention

Intervention type: Drug

Intervention name: 0 ul of dexmedetomidine

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

Arm group label: 0 ng/ml

Intervention type: Drug

Intervention name: 0.25 ul of dexmedetomidine

Description: 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

Arm group label: 0.5 ng/ml

Intervention type: Drug

Intervention name: 0.5 ul of dexmedetomidine

Description: 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

Arm group label: 1.0 ng/ml

Intervention type: Drug

Intervention name: 0.75 ul of dexmedetomidine

Description: 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

Arm group label: 1.5 ng/ml

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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: All

Minimum age: 20 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Hyo-Seok Na, MD., PhD. Principal Investigator Seoul National University Bundang Hospital
Overall Contact

Last name: Hyo-Seok Na, MD., PhD.

Phone: +82-31-787-7507

Email: [email protected]

Location
facility status contact investigator
Seoul National University Bundang Hospital Recruiting Hyoseok Na, pf 82-31-787-7507 [email protected] Hyoseok Na, pf Principal Investigator
Location Countries

Korea, Republic of

Verification Date

March 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Seoul National University Bundang Hospital

Investigator full name: Hyo-Seok Na

Investigator title: Associate Professor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: 0 ng/ml

Description: Blood specimen which was added 0 ul of dexmedetomidine

Arm group label: 0.5 ng/ml

Description: Blood specimen which was added 0.25 ul of dexmedetomidine

Arm group label: 1.0 ng/ml

Description: Blood specimen which was added 0.5 ul of dexmedetomidine

Arm group label: 1.5 ng/ml

Description: Blood specimen which was added 0.75 ul of dexmedetomidine

Study Design Info

Observational model: Case-Control

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov