The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.

Anhui Provincial Children's Hospital

Status and phase: Unknown; Phase 4

Conditions: Failed Conscious Sedation During Procedure

Treatments: Other: assessment; Drug: Fentanyl; Drug: Dexmedetomidine; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT02296073

PICUDEX2014

Details and patient eligibility

About

To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 month to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. written informed consent；
2. pediatric patients admitted to intensive care unit after general anesthesia;
3. expected mechanical ventilation time >6 hours; （4）1 months to 16 years old; -

Exclusion criteria

1. congenital heart disease, arrhythmias and heart failure;
2. Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
3. Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
4. central nervous system disease;
5. spinal analgesia or muscle relaxants is used during PICU;
6. the drug that affects the nerve conduction is used in one month;
7. allergy to the test drug or having other contraindications;
8. participated in other studies 30 days prior to admission of PICU; -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Midazolam

Experimental group

Description:

midazolam 3～5μg/kg•min for maintenance of sedation.

Treatment:

Other: assessment

Drug: Midazolam

Drug: Fentanyl

Dexmedetomidine1

Experimental group

Description:

Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；

Treatment:

Other: assessment

Drug: Fentanyl

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Dexmedetomidine2

Experimental group

Description:

Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；

Treatment:

Other: assessment

Drug: Fentanyl

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Dexmedetomiding3

Experimental group

Description:

Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；

Treatment:

Other: assessment

Drug: Fentanyl

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine