The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children

Study Overview
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Brief Summary
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The purpose of this study is to explore the optimal protocol for dexmedetomidine used in children during perioperative period.

Official Title
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The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children : A Single Center ,Randomized ,Double-blinded, Controlled Study.

Conditions
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The Efficacy and Safety of Intranasal Dexmedetomidine

Intervention / Treatment
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* Drug: Normal saline,1 milliliter
* Drug: Dexmedetomidine 1 μg.kg-1,1 milliliter
* Drug: Dexmedetomidine 2μg.kg-1,1 milliliter
* Drug: Anesthesia induction, 8% sevoflurane
* Drug: Anesthesia maintenance, 2% 3% sevoflurane,fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Elective cleft lip and cleft palate repair surgery American Society of Anesthesiologists class I Aged between 6 months and 7 years old Exclusion Criteria: Suspected or confirmed difficult airway History of upper respiratory tract infection with 1 month Combined with congenital heart disease Allergic to investigational products or with other contraindication Growth retardation or dysgnosia Central nervous system disease Serious infection Serious heart,brain,liver,kidney, pulmonary, and endocrine disease

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 7 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1,Normal saline,1 milliliter<br>Patients will be assigned to receive intranasal normal saline 1 milliliter | Drug: Normal saline,1 milliliter<br>* Normal saline,1 milliliter, 20 minutes before anaesthetic induction<br>Drug: Anesthesia induction, 8% sevoflurane<br>* Inhalation induction with 8% sevoflurane<br>Drug: Anesthesia maintenance, 2% 3% sevoflurane,fentanyl<br>* 2% 3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion<br>|
| Experimental: Group 2,dexmedetomidine 1μg.kg-1,1 milliliter<br>Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter | Drug: Dexmedetomidine 1 μg.kg-1,1 milliliter<br>* Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction<br>Drug: Anesthesia induction, 8% sevoflurane<br>* Inhalation induction with 8% sevoflurane<br>Drug: Anesthesia maintenance, 2% 3% sevoflurane,fentanyl<br>* 2% 3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion<br>|
| Experimental: Group 3,dexmedetomidine 2μg.kg-1,1 milliliter<br>Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter | Drug: Dexmedetomidine 2μg.kg-1,1 milliliter<br>* Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction<br>Drug: Anesthesia induction, 8% sevoflurane<br>* Inhalation induction with 8% sevoflurane<br>Drug: Anesthesia maintenance, 2% 3% sevoflurane,fentanyl<br>* 2% 3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation-Agitation Scale |  | The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction | 
| The pediatric anesthesia emergence delirium scale |  | The moment of entering operating room,and from discontinuation of inhalational anesthetics to the moment of patient's consciousness recovery,an expected average of 1 hour | 
| Anesthesia induction time |  | From beginning of inhalating anesthetics to the moment of intubation | 
| Anesthesia maintenance time |  | From the moment of intubation to the discontinuation of inhalational anesthestics | 
| Recovery time |  | From discontinuation of inhalational anesthestics to the moment of patient's consciousness recovery, an expected average of 1 hour | 
| Change from baseline in blood pressure during anesthesia |  | The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction | 
| Change from baseline in heart rate during anesthesia |  | The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction | 
| Change from baseline in respiratory rate during anesthesia |  | The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The alveolar concentration of inhalational anesthetics |  | the moment of anesthesia induction,the moment of intubation,before cutting skin | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The efficacy and safety of intranasal dexmedetomidine