Combination of Dexmedetomidine Nasal Spray and Remimazolam for the Treatment of Pediatric Bronchoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sedation success rate
研究概览
简要总结
To observe the sedative effect of using dexmedetomidine nasal spray combined with remimazolam for pediatric bronchoscopy diagnosis and treatment, provide a safer and more comfortable anesthesia plan for pediatric bronchoscopy diagnosis and treatment
详细描述
Dexmedetorimidine nasal spray is a new dosage form, which is simple and easy to achieve sedative and anti-anxiety effects by nasal spray mucosa. In the dose range from 50 to 100 μ g, the sedation effect increased dose-dependent, with> 2 μ g / kg administered, and the child could be successfully separated within 45min.Our study is to observe the sedative effect of using dexmedetomidine nasal spray combined with remimazolam for pediatric bronchoscopy diagnosis and treatment, provide a safer and more comfortable anesthesia plan for pediatric bronchoscopy diagnosis and treatment
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-6 years old (24~72 months);
- •ASA I-II;
- •sign the informed consent.
排除标准
- •Severe rhinitis, nasal deformity;
- •abnormal liver and kidney function;
- •severe dehydration, severe malnutrition, hypoproteinemia or anaemia Hb <10 g/dl;
- •children with neurological disease;
- •history of allergy to the study drug;
- •recent participation in other clinical studies.
研究组 & 干预措施
DR1 group
Dexmedetomidine injection 3μg/kg+ remimazolam 0.5mg/kg group
干预措施: Dexmedetomidine injection (Drug)
DR1 group
Dexmedetomidine injection 3μg/kg+ remimazolam 0.5mg/kg group
干预措施: Remimazolam (Drug)
DR2 group
Dexmedetomidine nasal spray 3μg/kg+ remimazolam 0.5mg/kg group
干预措施: Remimazolam (Drug)
结局指标
主要结局
Sedation success rate
时间窗: 1day
MOSS / A score =4-point time
次要结局
- recoving time(1day)
- Drug dosage(1day)