The Influence of Age on Dexmedetomidine Pharmacodynamic in Lower Extremity Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The ED50 of DEX
研究概览
简要总结
Dexmedetomidine(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects .At earlier time It was approved by the FDA only for short-time sedation during mechanical ventilation of adult patients (<24h) in ICU. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age and gender,such as the drug sensitivity of propofol and remifentanil is increased with age,while the current study also demonstrated that gender may influence the sedate efficacy of propofol and the sensitivity of muscle loose of rocuronium. Current studies with regard to the effects of age and gender on dexmedetomidine pharmacodynamic are rare. The study is aim to explore the right DEX dose of different Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the BIS,during the operation.The relation between BIS values and the depth of sedation for patients is also investigated.
详细描述
120 patients scheduled to undergo lower extremity surgery were included in one of three groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood up-and-down method. Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg, in the youth,and middle-aged group. The initial doses of DEX was 0.7 μg/kg,also with dose adjustment intervals of 0.05μg/kg.Sedative efficacy was defined as an OAA/S of ≤2, or an OAA/S of 3 but with an BIS value of ≤46, 26 min after the beginning of drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Ⅰ ~ Ⅱ patient undergoing lower extremity surgery
- •Written informed consent from the patient or the relatives of the participating patient.
- •BMI:18.5～25
排除标准
- •Mental illness can not match
- •epidural anesthesia contraindicated
- •People who have Slow-type arrhythmias
- •People who were language or hearing impaired
- •Sensory block reached to T8 or higher.
- •People who had lung infection or sleep apnea syndrome.
- •Chronic renal failure
- •Alcohol or drug abuse
- •Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
研究组 & 干预措施
Youth Group
People in this group, aged 18~39,were accepted an initial dose of 1μg/kg, with dose adjustment intervals of 0.05μg/kg.
干预措施: Dexmedetomidine 01 (Drug)
Middle-aged Group
People in this group, aged 40~64,were accepted an initial dose of 1μg/kg, with dose adjustment intervals of 0.05μg/kg.
干预措施: Dexmedetomidine 01 (Drug)
Older Group
People in this group, aged 65~80,were accepted an initial dose of 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg.
干预措施: Dexmedetomidine 02 (Drug)
结局指标
主要结局
The ED50 of DEX
时间窗: 26min after the start of the infusion
The aim of our study is to define the median effective sedative doses (ED50s) of DEX to determine the effect of age on the pharmacodynamic of DEX in lower extremity surgery using the Dixon and Mood up-and-down method。
次要结局
- The ED95 of DEX(26min after the start of the infusion)
研究者
bo xu
associate chief physician
Guangzhou General Hospital of Guangzhou Military Command