NCT04200235已完成1 期
Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- PK Cmax
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Able and willing to provide a written informed consent
- •Male or female
- •Subjects requiring elective general anesthesia surgery
- •Conform to the ASA Physical Status Classification
- •Meet the weight standard
排除标准
- •Not suitable for nasal spray
- •Pediatric populations requiring special care or court/social welfare supervision
- •Subjects who had been under general anesthesia were randomized
- •Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy
- •Subjects with previous abnormal behavior after medication
- •Subjects with cardiovascular disease
- •Clinically significant abnormal clinical laboratory test value
- •Subjects whose hemoglobin is below the lower limit of normal
- •Subjects who have either an adrenergic receptor agonist or an antagonist were randomized
- •Participated in clinical trials of other drugs before screening (accepted experimental drugs)
- •A history or possibility of difficult airway
- •History of hypersensitivity to drug ingredients or components
- •Other circumstances that the investigator judged inappropriate for participation in this clinical trial
研究组 & 干预措施
High weight group
Experimental
High weight group
干预措施: Dexmedetomidine hydrochloride nasal spray (Drug)
High weight group
Experimental
High weight group
干预措施: Dexmedetomidine hydrochloride nasal spray blank preparation. (Drug)
Low weight group
Experimental
Low weight group
干预措施: Dexmedetomidine hydrochloride nasal spray (Drug)
Low weight group
Experimental
Low weight group
干预措施: Dexmedetomidine hydrochloride nasal spray blank preparation. (Drug)
结局指标
主要结局
PK Cmax
时间窗: 0 to 1 hour after administration
Maximum blood concentration (Cmax)
次要结局
- Proportion of subjects with postoperative agitation(Up to 4 hours after the end of surgical operation)
- Proportion of subjects who parent-child separation successful(0 minute to 45 minutes after administration: every 15 minutes after administration)
- Total consumption of propofol(mg) during general anesthesia(From the beginning of anesthesia to the end of surgical operation up to 4 hours)
- Proportion of subjects who the Ramsay score is satisfactory at least once(0 minute to 45 minutes after administration: every 5 minutes after administration)
- Total consumption of opioid analgesic(μg) during general anesthesia(From the beginning of anesthesia to the end of surgical operation up to 4 hours)
- Proportion of subjects who the UMSS Scale is satisfactory at least once(0 minute to 45 minutes after administration: every 5 minutes after administration)
- Time of anesthesia awakening(Up to 4 hours after the end of surgical operation)
研究者
研究点 (1)
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