Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- CSF to Plasma Concentration Ratio
研究概览
简要总结
Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability that may affect that distribution.
Study procedures will include iv ondansetron administration, serial blood draws, cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years old;
- •Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
- •Ability to provide informed consent
排除标准
- •Not giving consent to participate in the study;
- •Patients with history of or current hepatic or renal insufficiency;
- •Patients with BMI ≥ 33;
- •Patients with heart failure or active arrhythmias;
- •Patients with severe systemic disease that is a constant threat to life;
- •Contraindication or allergy to ondansetron;
- •Pregnancy or lactation.
研究组 & 干预措施
open label infusion ondansetron
- A single 4-mL CSF sample per subject.
- Serial blood sampling at 0 (pre-infusion), 15, 30, 60, 120, and 180 min after ondansetron administration
干预措施: Ondansetron (Drug)
结局指标
主要结局
CSF to Plasma Concentration Ratio
时间窗: 0-180 min from the beginning of infusion
CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample
次要结局
未报告次要终点
研究者
simon.haroutounian
Assistant Professor
Washington University School of Medicine