UnknownPhase 4

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

120 participantsStarted 2014-12

Plain-language summary

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

Age range1 Month – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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; -

✕. 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; -

percentage of time at target sedation score

Timeframe: up to 24 hours

the number of patients requiring the sedation remedy

Timeframe: up to 24 hours

the dosage of midazolam that need for the sedation remedy

Timeframe: up to 24 hours

NCT IDNCT02296073

SponsorAnhui Provincial Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12