The Effect of Obesity in Dexmedetomidine Metabolic Clearance
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dexmedetomidine plasmatic levels
研究概览
简要总结
The purpose of this study is to study the effect of obesity in dexmedetomidine pharmacokinetics and pharmacodynamic profile.
详细描述
The investigators expect to find an inverse correlation between the amount of fat mass and liver blood flow or with the enzymatic metabolic capacity. Results will be based on a population pharmacokinetic modeling analysis performed in NONMEM program. The investigators will first account for the effect of different measured size scalars on volumes and clearances and then they will search for plausible covariates (liver blood flow, enzymatic capacity, degree of hepatic steatosis, etc) on dexmedetomidine metabolic clearance. A pharmacokinetic model capable of characterizing clearance changes in the obese using more plausible biological covariates will be tried to be defined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Known allergy to study drugs
- •Uncontrolled hypertension.
- •Heart block greater than first degree.
- •Chronic hepatic and kidney disease.
- •Patients taking any drug acting in the central nervous system within 24 hrs before surgery.
- •Patients taking drugs that induce overexpression of liver cytochrome P450-complex enzymes (Carbamazepine, Phenytoin, Phenobarbital, Rifampicin, Dexamethasone, Griseofulvin, Terbinafine, Prednisone, Hydrocortisone, Modafinil).)
- •Known addiction to illicit drugs.
- •Pregnancy.
- •Current or past oncologic disease.
研究组 & 干预措施
Obese
Body composition measurement before surgery using Dual energy X-ray absorptiometry. Dexmedetomidine infusion during surgery. Venous blood sampling for dexmedetomidine plasmatic levels during and after surgery. Liver blood flow indirect non-invasive assessment after surgery using indocyanine. Liver biopsy during surgery.
干预措施: Dexmedetomidine (Drug)
Non-obese
Body composition measurement before surgery using Dual energy X-ray absorptiometry. Dexmedetomidine infusion during surgery. Venous blood sampling for dexmedetomidine plasmatic levels during and after surgery. Liver blood flow indirect non-invasive assessment after surgery using indocyanine. Liver biopsy during surgery.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Dexmedetomidine plasmatic levels
时间窗: From start of infusion (min): 5, 10, 20, 30, 45, 60, 90, 120, 150, 180; from end of infusion (min): 5, 10, 20, 30, 60, 90, 120, 240, 360, 720
Measured by high performance liquid chromatography
次要结局
- Steatohepatitis score(3 months after liver biopsy specimen collection)
- Plasma disappearance rate of indocyanine(2 hours after arrival to Post-Anesthesia Care Unit)
- Enzyme expression(3 months after liver biopsy specimen collection)
- Hemodynamics(Recorded at every blood sample collection (5, 10, 20, 30, 45, 60, 90, 120, 150, 180 min) during anesthesia)
- Anesthetic depth(Recorded at every blood sample collection (5, 10, 20, 30, 45, 60, 90, 120, 150, 180 min) during anesthesia)