Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric

Chinese Medical Association

Status and phase: Unknown; Phase 4

Conditions: Pharmacodynamics; Pediatrics; Dexmedetomidine; Pharmacokinetics

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03337581

No.2017-62

Details and patient eligibility

About

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.

Enrollment: 187 estimated patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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187 participants in 5 patient groups

group 1.1

Sham Comparator group

Description:

Normal saline group

Treatment:

Drug: Dexmedetomidine

group 1.2

Experimental group

Description:

0.25μg/kg dexmedetomidine group

Treatment:

Drug: Dexmedetomidine

group 1.3

Experimental group

Description:

0.5μg/kg dexmedetomidine group

Treatment:

Drug: Dexmedetomidine

group 1.4

Experimental group

Description:

0.75μg/kg dexmedetomidine group

Treatment:

Drug: Dexmedetomidine

group 1.5

Experimental group

Description:

1.0μg/kg dexmedetomidine group

Treatment:

Drug: Dexmedetomidine