A Study of the Pharmacokinetics of Dexmedetomidine in Morbid Obesity.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma Concentration of dexmedetomidine
研究概览
简要总结
Dexmedetomidine hydrochloride ,a relatively new drug in Chinais ,is a highly selective, potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects. The morbid obesity in Chinese population is rapidly increasing. But the pharmacokinetics of the drug in these people is still unknown.This research was designed to study the pharmacokinetics of dexmedetomidine in Chinese morbidly obese population.
详细描述
For the obese are sensitive to the disease such as hypertension, ischaemic heart disease and diabetes, the changes of the state may affect the pharmacokinetics of dexmedetomidine. Besides,the clearance of dexmedetomidine is parallel with liver function and it is excreted by kidney, so differences in the obese may be expected.
About 10 obese patients and 10 matched healthy volunteers with normal weight would be chosen to receive a normal dosage of dexmedetomidine. And venous samples will be collected in different time points. Next the investigators can get the plasma concentration of dexmedetomidine by the use of HPLC-MS. And then the plasma concentration could be analyzed.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weight:28≦BMI≦45 and 18.5≦BMI≦24
- •Written informed consent from the patient or the relatives of the participating patient.
排除标准
- •A previous history of intolerance to the study drug or related compounds and additives.
- •Existing significant haematological, endocrine, metabolic or gastrointestinal disease.
研究组 & 干预措施
Dexmedetomidine
Each team will be administered for 1μg/kg of dexmedetomidine eace one.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Plasma Concentration of dexmedetomidine
时间窗: 0, 5, 10, 15, 20, 25, 30, 45 , 60, 90, 120, 150,180,240,360,480 hours post-dose
次要结局
未报告次要终点
研究者
bo xu
associate chief physician
Guangzhou General Hospital of Guangzhou Military Command