Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric
NCT ID: NCT03337581
Last Updated: 2017-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
187 participants
INTERVENTIONAL
2017-10-20
2019-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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group 1.1
Normal saline group
Dexmedetomidine
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group 1.2
0.25μg/kg dexmedetomidine group
Dexmedetomidine
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group 1.3
0.5μg/kg dexmedetomidine group
Dexmedetomidine
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group 1.4
0.75μg/kg dexmedetomidine group
Dexmedetomidine
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group 1.5
1.0μg/kg dexmedetomidine group
Dexmedetomidine
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Interventions
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Dexmedetomidine
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
9 Years
ALL
No
Sponsors
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Chinese Medical Association
NETWORK
Responsible Party
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Principal Investigators
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Huacheng Liu
Role: STUDY_DIRECTOR
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Locations
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The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jie Chen
Role: primary
Xueqiong Zhu
Role: backup
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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No.2017-62
Identifier Type: -
Identifier Source: org_study_id