Status:

UNKNOWN

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

Lead Sponsor:

Anhui Provincial Children's Hospital

Conditions:

Failed Conscious Sedation During Procedure

Eligibility:

All Genders

1-16 years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

December 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2015

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT02296073

Start Date

December 1 2014

End Date

December 1 2015

Last Update

November 21 2014

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