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

Anhui Provincial Children's Hospital120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Failed Conscious Sedation During Procedure

Interventions

MidazolamDRUG

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

DexmedetomidineDRUG

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

DexmedetomidineDRUG

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

Eligibility

Sex: ALLMin age: 1 MonthMax age: 16 Years

Medical Language ↔ Plain English

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; -

Outcomes

Primary Outcomes

percentage of time at target sedation score

assess the sedation level every 2 min using Ramsay score

Time frame: up to 24 hours

the number of patients requiring the sedation remedy

the number of patients requiring the sedation remedy during the mechanical ventilation

Time frame: up to 24 hours

the dosage of midazolam that need for the sedation remedy

the dosage of midazolam that need for sedation remedy during the mechanical ventilation

Time frame: up to 24 hours

Secondary Outcomes

change of blood pressure

the change of blood pressure at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.

Time frame: up to 24 hours.

change of heart rate

the change of heart rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.

Time frame: up to 24 hours

change of respiratory rate

the change of respiratory rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.

Time frame: up to 24 hours

change of blood oxygen saturation

the change of blood oxygen saturation at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.

Data from ClinicalTrials.gov

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