The Efficacy and Safety of Intranasal Dexmedetomidine Clinical Trial
Official title:
The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children : A Single Center ,Randomized ,Double-blinded, Controlled Study.
| Verified date | August 2014 |
| Source | Xijing Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to explore the optimal protocol for dexmedetomidine used in children during perioperative period.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | December 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Months to 7 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Xijing Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sedation-Agitation Scale | The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction | No | |
| Primary | 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 | No | |
| Primary | Anesthesia induction time | From beginning of inhalating anesthetics to the moment of intubation | No | |
| Primary | Anesthesia maintenance time | From the moment of intubation to the discontinuation of inhalational anesthestics | No | |
| Primary | Recovery time | From discontinuation of inhalational anesthestics to the moment of patient's consciousness recovery, an expected average of 1 hour | No | |
| Primary | 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 | Yes | |
| Primary | 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 | Yes | |
| Primary | 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 | Yes | |
| Secondary | The alveolar concentration of inhalational anesthetics | the moment of anesthesia induction,the moment of intubation,before cutting skin | Yes |