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NCT03337581 Clinical Trial

Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric

Pharmacokinetics Clinical Trial

Official title:
The Safety态Efficacy and Pharmacokinetics of Dexmedetomidine Administered Through Different Routes in Pediatric

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03337581
Other study ID # No.2017-62
Secondary ID
Status Recruiting
Phase Phase 4
First received September 1, 2017
Last updated November 7, 2017
Start date October 20, 2017
Est. completion date July 2019

Study information
Verified date August 2017
Source Chinese Medical Association
Contact Fang Chen
Phone +86 13957776300
Email 15254896@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 187
Est. completion date July 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 3 Years to 9 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
see arms

Locations
Country Name City State
China The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Wenzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute Hemodynamic and respiratory Changes After Rapid Intravenous of Dexmedetomidine Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric up to 4 months
Primary Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric 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
Primary Pharmacokinetics of Dexmedetomidine administered as a nasal spray 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
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