A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation With Administration of Oral, Intravenous and Nasal Drops
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Dexmedetomidine pharmacokinetic curve
研究概览
简要总结
Proper preoperative sedation can reduce patients' anxiety, enhance patients' cooperation and reduce perioperative complications. The investigators would explore the sedative effects of dexmedetomidine (DEX) with the administration of oral, intravenous and nasal drops, and detect DEX blood concentration in 15 participants, respectively. Pharmacokinetic parameters are detected at 8 time points ( before DEX administration, 10 min, 20 min, 30 min, 45 min, 60min, 90min and 120 min after administration). 3 ml arterial blood was collected at each time point. The blood samples are detected by mass spectrometer. The aim of this study is to investigate appropriate administration time and route for DEX sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 participants who undergo tympanoplasty would be enrolled after signment the informed consent.
排除标准
- •The participants were excluded with any diseases about respiration, circulation, liver and kidney.
研究组 & 干预措施
oral administration
oral administration of dexmedetomidine 4μg/kg
干预措施: Dexmedetomidine (Drug)
intravenous administration
intravenous administration of dexmedetomidine 0.8μg/kg
干预措施: Dexmedetomidine (Drug)
nasal administration
nasal administration of dexmedetomidine 1μg/kg
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Dexmedetomidine pharmacokinetic curve
时间窗: 120 min DEX pharmacokinetics
Dexmedetomidine (DEX) blood concentration are detected at 8 time points (before DEX administration, 10 min, 20 min, 30 min, 45 min, 60min, 90min and 120 min after administration) in the groups of oral, intravenous and nasal drops administration of DEX. 3 ml arterial blood was collected at each time point. The blood samples are detected by mass spectrometer to detect blood concentration of DEX. Then DEX pharmacokinetic curve is made according to the DEX blood concentration.
次要结局
- Effect of sedation(10min after administration)
- Evaluation of surgical field(30min after administration)
研究者
Jinhong Wu
Principal Investigator
Eye & ENT Hospital of Fudan University