The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Serum level of dexmedetomidine
研究概览
简要总结
Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical patients frequently come to the operating room on anticonvulsant therapy with a history of seizures. The investigators clinical experience suggests that these patients are resistant to the sedative effects of dexmedetomidine. This effect may represent a pharmacokinetic interaction between the anticonvulsant medications and dexmedetomidine or the higher dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the underlying seizure disorder. The investigators study aims to investigate the pharmacokinetic and pharmacodynamic differences of dexmedetomidine between patients receiving and not receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for these differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65, BMI 20-25 kg/m2
- •Anticonvulsant Group: Diagnosis of seizure disorder taking carbamazepine or phenytoin for a minimum of 2 weeks
- •Control Group: Healthy volunteers taking no medications
排除标准
- •Positive urine pregnancy test or lactating
- •History of allergy to dexmedetomidine or alpha -2 agonists
- •History of liver, renal or thyroid disease
- •History of cardiovascular disease including history of arrhythmia or congestive heart failure
- •History of drug or alcohol abuse
结局指标
主要结局
Serum level of dexmedetomidine
时间窗: 0-8 hour period
Serum levels of dexmedetomidine will be taken at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
次要结局
- Patient State Index (PSI) and Entropy(0-8h)
- Visual Analog Scale score(0-8h)
- Ramsay Sedation Score(0-8h)
- Observer's Assessment of Alertness/Sedation Score (OAA/S)(0-8h)
