The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.
- Conditions
- Failed Conscious Sedation During Procedure
- Interventions
- Registration Number
- NCT02296073
- Lead Sponsor
- Anhui Provincial Children's Hospital
- Brief Summary
To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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; -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Midazolam Fentanyl midazolam 3～5μg/kg•min for maintenance of sedation. Dexmedetomidine2 assessment Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Midazolam assessment midazolam 3～5μg/kg•min for maintenance of sedation. Dexmedetomidine1 assessment Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Dexmedetomiding3 assessment Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； Dexmedetomiding3 Fentanyl Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； Midazolam Midazolam midazolam 3～5μg/kg•min for maintenance of sedation. Dexmedetomidine1 Dexmedetomidine Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Dexmedetomidine1 Fentanyl Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Dexmedetomidine2 Fentanyl Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Dexmedetomidine2 Dexmedetomidine Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Dexmedetomiding3 Dexmedetomidine Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；
- Primary Outcome Measures
Name Time Method percentage of time at target sedation score up to 24 hours assess the sedation level every 2 min using Ramsay score
the number of patients requiring the sedation remedy up to 24 hours the number of patients requiring the sedation remedy during the mechanical ventilation
the dosage of midazolam that need for the sedation remedy up to 24 hours the dosage of midazolam that need for sedation remedy during the mechanical ventilation
- Secondary Outcome Measures
Name Time Method the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used up to 24 hours change of blood oxygen saturation up to 24 hours 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.
change of respiratory rate up to 24 hours 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.
extubation time up to 24 hours time from beginning of study drug used to extubation
the dosage of sedation and analgesia drug up to 24 hours the total dosage of sedation and analgesia drug during the sedation and analgesia period
change of blood pressure up to 24 hours. 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.
change of heart rate up to 24 hours 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.
change of hepatic function up to 24 hours change of blood ALT、AST level at baseline and 24 hours after the sedation drug used.
the dosage of fentanyl in and after 6 hours from study drug used up to 24 hours change of renal function up to 24 hours change of blood Cr、BUN level at baseline and 24 hours after the sedation drug used.