Clinical trial NCT02222636: The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children
Official title: The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children : A Single Center ,Randomized ,Double-blinded, Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: The Efficacy and Safety of Intranasal Dexmedetomidine
Keywords: The efficacy and safety of intranasal dexmedetomidine
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Sedation-Agitation Scale
timeFrame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
measure: The pediatric anesthesia emergence delirium scale
timeFrame: 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
measure: Anesthesia induction time
timeFrame: From beginning of inhalating anesthetics to the moment of intubation
measure: Anesthesia maintenance time
timeFrame: From the moment of intubation to the discontinuation of inhalational anesthestics
measure: Recovery time
timeFrame: From discontinuation of inhalational anesthestics to the moment of patient's consciousness recovery, an expected average of 1 hour
measure: Change from baseline in blood pressure during anesthesia
timeFrame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
measure: Change from baseline in heart rate during anesthesia
timeFrame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
measure: Change from baseline in respiratory rate during anesthesia
timeFrame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Secondary outcomes:
measure: The alveolar concentration of inhalational anesthetics
timeFrame: the moment of anesthesia induction,the moment of intubation,before cutting skin
Other outcomes:
Locations:
Study officials:
References: