The ED50 of DEX for Providing Sedation in Different Female Age Group
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The ED50 of DEX for providing sedation
研究概览
简要总结
Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects. 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 current studies with regard to the effects of age on dexmedetomidine pharmacodynamic are rare. This study was designed to explore the right DEX dose of different female 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 Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of sedation for patients is also investigated.
详细描述
90 patients scheduled for combined spinal epidural spinal anesthesia were included in one of three groups. In each group,determination of median effective (ED50) doses was performed by the Dixon up-and-down method, an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1 μg/kg in first three turning points and 0.05μg/kg in the last three turning points.Initial doses was 1.4μg/kg, .Sedative efficacy was defined as an OAA/S of ≤3,30 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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 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:18.0～25.0kg/m2
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 female group
patients in the Youth female group, aged 20~35, were accepted an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
干预措施: Dexmedetomidine A (Drug)
Middle-aged female group
patients in the Middle-aged female group, aged 40~60, were accepted an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
干预措施: Dexmedetomidine B (Drug)
Elderly female group
Patient in the elderly female group, aged 65~79, were accepted an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
干预措施: Dexmedetomidine C (Drug)
结局指标
主要结局
The ED50 of DEX for providing sedation
时间窗: 30min after the start of the infusion
The aim of this study is to define the optimum bolus dose (ED50) of dexmedetomidine for producing adequate sedation during spinal anesthesia in different female age group using the Dixon and Mood up-and-down method。
次要结局
- The ED95 of DEX(30min after the start of the infusion)
研究者
bo xu
associate chief physician
Guangzhou General Hospital of Guangzhou Military Command