Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric

November 7, 2017 updated by: Chinese Medical Association

The Safety、Efficacy and Pharmacokinetics of Dexmedetomidine Administered Through Different Routes in Pediatric

  1. Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric.
  2. Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric.
  3. Pharmacokinetics after a single dose of Dexmedetomidine administered as a nasal spray in Pediatric.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

187

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chengyu Wang

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

3 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • selective operation of inguinal hernia repair、orthopedics operation or general surgery operation in children
  • aged 3-9 years
  • ASA I - II
  • enter the operating room by himself without parents
  • normal liver and kidney function
  • no history of anesthesia medication allergy.

Exclusion Criteria:

  • allergic to dexmedetomidine, similar active ingredients or excipients
  • G-6-PD deficiency
  • a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on
  • a history of use of alpha 2 receptor agonists or antagonists.

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: group 1.1
Normal saline group
Drug: Dexmedetomidine
see arms
EXPERIMENTAL: group 1.2
0.25μg/kg dexmedetomidine group
Drug: Dexmedetomidine
see arms
EXPERIMENTAL: group 1.3
0.5μg/kg dexmedetomidine group
Drug: Dexmedetomidine
see arms
EXPERIMENTAL: group 1.4
0.75μg/kg dexmedetomidine group
Drug: Dexmedetomidine
see arms
EXPERIMENTAL: group 1.5
1.0μg/kg dexmedetomidine group
Drug: Dexmedetomidine
see arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Hemodynamic and respiratory Changes After Rapid Intravenous of Dexmedetomidine
Time Frame: up to 4 months
Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric
up to 4 months
Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric
Time Frame: up to 6 months
After a single Rapid Intravenous dose of Dexmedetomidine in Pediatric，blood samples will be collected ,and dexmedetomidine plasma concentrations were measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).
up to 6 months
Pharmacokinetics of Dexmedetomidine administered as a nasal spray
Time Frame: up to 6 months
After a single dose of Dexmedetomidine administered as a nasal spray in Pediatric,blood samples will be collected ,and dexmedetomidine plasma concentrations were measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).
up to 6 months

Collaborators and Investigators

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

Sponsor

Chinese Medical Association

Investigators

  • Study Director: Huacheng Liu, The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

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)

October 20, 2017

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

September 1, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (ACTUAL)

November 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.2017-62

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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