The Efficacy and Safety of Intranasal Dexmedetomidine
Conditions
Keywords
The efficacy and safety of intranasal dexmedetomidine
Brief summary
The purpose of this study is to explore the optimal protocol for dexmedetomidine used in children during perioperative period.
Interventions
DRUGNormal saline,1 milliliter
Normal saline,1 milliliter, 20 minutes before anaesthetic induction
DRUGDexmedetomidine 1 μg.kg-1,1 milliliter
Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction
DRUGDexmedetomidine 2μg.kg-1,1 milliliter
Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction
DRUGAnesthesia induction, 8% sevoflurane
Inhalation induction with 8% sevoflurane
DRUGAnesthesia maintenance, 2%~3% sevoflurane,fentanyl
2%\ 3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| The alveolar concentration of inhalational anesthetics | the moment of anesthesia induction,the moment of intubation,before cutting skin |
Outcome results
None listed