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

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

Official Title
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The Efficacy and the Safety of Dexmedetomidine Sedation on the PICU Patients-A Randomized, Controlled Study.

Conditions
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Failed Conscious Sedation During Procedure

Intervention / Treatment
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* Drug: Midazolam
* Drug: Dexmedetomidine
* Drug: Dexmedetomidine
* Drug: Dexmedetomidine
* Drug: Fentanyl
* Other: assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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; -

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam<br>midazolam 3～5μg/kg•min for maintenance of sedation. | Drug: Midazolam<br>* midazolam 3～5μg/kg•min for maintenance of sedation.<br>* Other names: Liyuexi;Drug: Fentanyl<br>* Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia<br>* Other names: Fentai;Other: assessment<br>* Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.<br>|
| Experimental: Dexmedetomidine1<br>Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； | Drug: Dexmedetomidine<br>* Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；<br>* Other names: Yisi;Drug: Fentanyl<br>* Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia<br>* Other names: Fentai;Other: assessment<br>* Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.<br>|
| Experimental: Dexmedetomidine2<br>Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； | Drug: Dexmedetomidine<br>* Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；<br>* Other names: Yisi;Drug: Fentanyl<br>* Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia<br>* Other names: Fentai;Other: assessment<br>* Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.<br>|
| Experimental: Dexmedetomiding3<br>Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； | Drug: Dexmedetomidine<br>* Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；<br>* Other names: Yisi;Drug: Fentanyl<br>* Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia<br>* Other names: Fentai;Other: assessment<br>* Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of time at target sedation score | assess the sedation level every 2 min using Ramsay score | up to 24 hours | 
| the number of patients requiring the sedation remedy | the number of patients requiring the sedation remedy during the mechanical ventilation | 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 | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | up to 24 hours | 
| extubation time | time from beginning of study drug used to extubation | up to 24 hours | 
| change of hepatic function | change of blood ALT、AST level at baseline and 24 hours after the sedation drug used. | up to 24 hours | 
| change of renal function | change of blood Cr、BUN level at baseline and 24 hours after the sedation drug used. | up to 24 hours | 
| the dosage of sedation and analgesia drug | the total dosage of sedation and analgesia drug during the sedation and analgesia period | up to 24 hours | 
| the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used |  | up to 24 hours | 
| the dosage of fentanyl in and after 6 hours from study drug used |  | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric intensive care unit, Sedation, Dexmedetomidine, mechanical ventilation