Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric

Phase 4

• Conditions: Pediatrics; Dexmedetomidine; Pharmacodynamics; Pharmacokinetics
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT03337581
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-09-01
• Study Start: 2017-10-20
• Study First Submitted QC: 2017-11-07
• Last Update Submitted: 2017-11-07
• Study First Posted: 2017-11-09
• Last Update Posted: 2017-11-09
• Primary Completion: 2018-12
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 187

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1.5	Dexmedetomidine	1.0μg/kg dexmedetomidine group
group 1.1	Dexmedetomidine	Normal saline group
group 1.2	Dexmedetomidine	0.25μg/kg dexmedetomidine group
group 1.3	Dexmedetomidine	0.5μg/kg dexmedetomidine group
group 1.4	Dexmedetomidine	0.75μg/kg dexmedetomidine group

Primary Outcome Measures

Name	Time	Method
Acute Hemodynamic and respiratory Changes After Rapid Intravenous of Dexmedetomidine	up to 4 months	Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric
Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric	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).
Pharmacokinetics of Dexmedetomidine administered as a nasal spray	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).

Trial Locations

Locations (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China