Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children

April 13, 2020 updated by: Hee-Soo Kim, Seoul National University Hospital

Pharmacokinetic-pharmacodynamic Analysis for Dosing Strategy and Evaluation of Safety and Efficacy of Dexmedetomidine in Children

This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children under sedation at intensive care unit after surgery. Patients will receive dexmedetomidine intravenously for 50 minutes after surgery as as sedation drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dexmedetomidine, an alpha-2 adrenergic agonist, is being effectively used for procedural sedation or sedation at intensive care unit. However, the safety and efficacy profile are not yet established for children. Although there have been some studies regrading it, still there is no public guideline, therefore making it difficult to use dexmedetomidine in children.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jongro Gu
      • Seoul, Jongro Gu, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric patients planned to undergo mechanical ventilation at intensive care unit after surgery
  • Pediatric patients planned to be extubated within 4 hours after surgery for neurological examination
  • Patients whose parent of legal guardian agreed to enroll in the study after having enough time to review the complete explanation about the study.

Exclusion Criteria:

  • History of hypersensitivity to any drugs including dexmedetomidine.
  • Underlying cardiovascular/circulatory disease
  • Underlying liver / kidney disease
  • Patients under hemodialysis
  • Obesity of BMI > 35
  • Patients planned to receive patient-controlled analgesia including opioids
  • Patients whose parent or legal guardian declined to enroll in the study
  • Other conditions deemed unsuitable for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine
Intravenous infusion of dexmedetomidine for 50 min after surgery at intensive care unit
Drug: Dexmedetomidine Hydrochloride
Intravenous infusion of dexmedetomidine at the rate of 0.5mcg/kg for 10 min, then 0.5mcg/kg/hr for 50 min.
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentration of dexmedetomidine
Time Frame: From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion
Plasma concentration of dexmedetomidine before infusion, 10/30/60 minutes after initiation of infusion, 15/30/60/120/240/480 minutes after end of infusion
From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion
Bispectral index
Time Frame: From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion
Bispectral index based on electroencephalogram during patient's stay at intensive care unit (0-100, lower score implies deeper sedation)
From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion
University of Michigan Sedation Scale
Time Frame: From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion
University of Michigan Sedation Scale based on observer's inspection during patient's stay at intensive care unit (0-4, higher score implies deeper sedation)
From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of arrhythmia
Time Frame: From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Presence of any kind of arrhythmia from electrocardiogram following dexmedetomidine infusion
From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Non-invasive blood pressure
Time Frame: From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Non-invasive blood pressure in units of mmHg, to examine whether hypertension (increase in blood pressure more than 20% of baseline) or hypotension (decrease in blood pressure more than 20% of baseline) occurs
From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Incidence of desaturation
Time Frame: From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Presence of desaturation (pulse oximetry of lower than 94%) following dexmedetomidine infusion
From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Respiratory rate
Time Frame: From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Respiratory rate in units of /min, to examine whether respiratory depression or apnea occurs
From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Incidence of nausea
Time Frame: From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Incidence of nausea following dexmedetomidine infusion
From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Incidence of vomiting
Time Frame: From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion
Incidence of vomiting following dexmedetomidine infusion
From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Food and Drug Safety, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2019

Primary Completion (Actual)

November 14, 2019

Study Completion (Actual)

November 14, 2019

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1905-188-1037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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