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临床试验/NCT01116700
NCT01116700已完成1 期

The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2010年12月最近更新:
适应症
相关药物

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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