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Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric

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ClinicalTrials.gov Identifier: NCT03337581
Recruitment Status : Unknown
Verified August 2017 by Chinese Medical Association.
Recruitment status was:  Recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Chinese Medical Association

Brief Summary:
  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.

Condition or disease Intervention/treatment Phase
Pediatrics Dexmedetomidine Pharmacodynamics Pharmacokinetics Drug: Dexmedetomidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Safety、Efficacy and Pharmacokinetics of Dexmedetomidine Administered Through Different Routes in Pediatric
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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).

  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337581


Contacts
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Contact: Fang Chen +86 13957776300 15254896@qq.com
Contact: Chengyu Wang +8615158719196 15158719196@163.com

Locations
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China, Zhejiang
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325027
Contact: Jie Chen    0577-88002560    feykjkcy@126.com   
Contact: Xueqiong Zhu    0577-88002560    feykjkcy@126.com   
Principal Investigator: Chengyu Wang         
Sponsors and Collaborators
Chinese Medical Association
Investigators
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Study Director: Huacheng Liu The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
  Study Documents (Full-Text)

Documents provided by Chinese Medical Association:
Study Protocol  [PDF] October 12, 2017
Statistical Analysis Plan  [PDF] October 12, 2017
Informed Consent Form  [PDF] October 12, 2017


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Responsible Party: Chinese Medical Association
ClinicalTrials.gov Identifier: NCT03337581     History of Changes
Other Study ID Numbers: No.2017-62
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: August 2017

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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

Keywords provided by Chinese Medical Association:
Dexmedetomidine
pediatrics
Pharmacodynamics
Pharmacokinetics

Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action