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The safety, efficacy and pharmacokinetics of dexmedetomidine administered through different routes in pediatric

The safety, efficacy and pharmacokinetics of dexmedetomidine administered through different routes in pediatric

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012518
Enrollment
Unknown
Registered
2017-09-02
Start date
2017-09-01
Completion date
Unknown
Last updated
2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediarteric Disease

Interventions

control group: saline
0.25ug/kg dexmedetomidine group:rapid injection of 0.25ug/kg dexmedetomidine and measure the oncentration
0.5ug/kg dexmedetomidine group:rapid injection of 0.5ug/kg dexmedetomidine and measure the oncentration
0.75ug/kg dexmedetomidine group:rapid injection of 0.75ug/kg dexmedetomidine and measure the oncentration
1.0ug/kg dexmedetomidine group:rapid injection of 1.0ug/kg dexmedetomidine and measure the oncentration
1.0ug/kg intranasal dexmedetomidine group:1.0ug/kg intranasal dexmedetomidine and measure the oncentration
1.5ug/kg intranasal dexmedetomidine group:1.5ug/kg intranasal dexmedetomidine and measure the oncentration
2.0ug/kg intranasal dexmedetomidine group:2.0ug/kg intranasal dexmedetomidine and measure the oncentration

Sponsors

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 9 Years

Inclusion criteria

Inclusion criteria: (1) selective operation of inguinal hernia repair,orthopedics operation or general surgery operation in children; (2) aged 3-9 years; (3) ASA I - II; (4) enter the operating room by himself without parents; (5) normal liver and kidney function; (6) no history of anesthesia medication allergy.

Exclusion criteria

Exclusion criteria: (1) allergic to dexmedetomidine, similar active ingredients or excipients; (2) G-6-PD deficiency; (3) a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on; (4) a history of use of alpha 2 receptor agonists or antagonists.

Design outcomes

Primary

MeasureTime frame
heart rate;plasma concentration;

Secondary

MeasureTime frame
Emergence Agitation;blood pressure;Respiratory frequency;Tidal volume;

Countries

China

Contacts

Public ContactFang Chen

The Scecond Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

15254896@qq.com+86 13957776300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026