The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children : A Single Center ,Randomized ,Double-blinded, Controlled Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 主要终点
- Sedation-Agitation Scale
研究概览
简要总结
The purpose of this study is to explore the optimal protocol for dexmedetomidine used in children during perioperative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1,Normal saline,1 milliliter
Patients will be assigned to receive intranasal normal saline 1 milliliter
干预措施: Normal saline,1 milliliter (Drug)
Group 1,Normal saline,1 milliliter
Patients will be assigned to receive intranasal normal saline 1 milliliter
干预措施: Anesthesia induction, 8% sevoflurane (Drug)
Group 1,Normal saline,1 milliliter
Patients will be assigned to receive intranasal normal saline 1 milliliter
干预措施: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl (Drug)
Group 2,dexmedetomidine 1μg.kg-1,1 milliliter
Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter
干预措施: Dexmedetomidine 1 μg.kg-1,1 milliliter (Drug)
Group 2,dexmedetomidine 1μg.kg-1,1 milliliter
Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter
干预措施: Anesthesia induction, 8% sevoflurane (Drug)
Group 2,dexmedetomidine 1μg.kg-1,1 milliliter
Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter
干预措施: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl (Drug)
Group 3,dexmedetomidine 2μg.kg-1,1 milliliter
Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter
干预措施: Dexmedetomidine 2μg.kg-1,1 milliliter (Drug)
Group 3,dexmedetomidine 2μg.kg-1,1 milliliter
Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter
干预措施: Anesthesia induction, 8% sevoflurane (Drug)
Group 3,dexmedetomidine 2μg.kg-1,1 milliliter
Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter
干预措施: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl (Drug)
结局指标
主要结局
Sedation-Agitation Scale
时间窗: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Anesthesia maintenance time
时间窗: From the moment of intubation to the discontinuation of inhalational anesthestics
Anesthesia induction time
时间窗: From beginning of inhalating anesthetics to the moment of intubation
Change from baseline in heart rate during anesthesia
时间窗: 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
时间窗: 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
Change from baseline in respiratory rate during anesthesia
时间窗: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Recovery time
时间窗: 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
时间窗: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
次要结局
- The alveolar concentration of inhalational anesthetics(the moment of anesthesia induction,the moment of intubation,before cutting skin)
研究者
wangqiang
department of anesthesijology
Xijing Hospital