Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection in Adult Patients With General Anesthesia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- BIS
研究概览
简要总结
Propofol is a widely used sedative anesthetic, but there are large individual differences, which making different patients with different sensitivity to propofol. The aim of this study was to analyze the effects of age, height, body weight, Drinking, metabolic enzymes CYP2B6 and UGT1A9 on Pharmacological effects and pharmacokinetics of propofol, and to provide a reasonable reference for clinical anesthesia patients and evidence for individual dosage regimens.
详细描述
Propofol is a widely used sedative anesthetic, but there are large individual differences, which making different patients with different sensitivity to propofol. In recent years, the concept of individualized administration came into being.Individual administration refers to according to the condition of patients,the drug's safety and efficacy, and pharmacokinetics, pharmacodynamics and clinical response ,then gives different dosing regimens for individual patients and promotes the development of rational drug use. Different people have differences metabolism of propofol, reported in the literature, genetic polymorphism, demographic characteristics, combined with drug and other variability factors, all of them will affect the pharmacokinetics and pharmacodynamics of propofol.The aim of this study was to analyze the effects of age, height, body weight, Drinking, metabolic enzymes CYP2B6 and UGT1A9 on Pharmacological effects and pharmacokinetics of propofol, and to provide a reasonable reference for clinical anesthesia patients and evidence for individual dosage regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •patients aged 18-60 years (including those aged 18 and 60) who underwent gastrointestinal endoscopy;
- •weight should not be less than (≥) 50kg, not more than (≤) 80kg. Body mass index (BMI) = body weight kg / [(height m) 2], in the normal range of 19 to 25;
- •American Society of Anesthesiologists (ASA) grading (Appendix I): I or II;
- •no heart, liver, lung, kidney, digestive tract, nervous system, mental disorders and other medical history, no blood and metabolic diseases and other medical history, no potential difficulties airway and special past history,
- •blood, urine, stool routine, liver and kidney function, blood lipids, ECG, chest X-ray and blood pressure normal, or abnormal but no clinical significance, the researchers believe that can be grouped.
- •agree and sign informed consent.
排除标准
- •important organs have primary disease;
- •persons with mental or physical disabilities;
- •those suffering from neurological or mental illness, a history of epilepsy;
- •patients with cardiovascular or respiratory insufficiency and hypovolemia;
- •obese or those with dyslipidemia;
- •hereditary acute porphyria;
- •infections, especially those with respiratory and central infections;
- •language exchange barriers;
- •suspected or indeed a history of alcohol, drug abuse; especially long-term use of non-steroidal anti-inflammatory drugs, opioids, tranquilizers;
- •allergies, if the history of drugs or food allergies; or known to propofol, soybeans, peanuts, coconut oil allergy;
- •smoking history (smoking ≥ 5 per day);
- •2 weeks before the trial had used all kinds of Chinese and Western medicine;
- •the last 3 months of blood donors and test blood donors;
- •other circumstances that the researcher thinks can not be grouped (eg, frail, etc.).
研究组 & 干预措施
External control
propofol;injection;2mg/kg;single-dose
干预措施: Propofol (Drug)
结局指标
主要结局
BIS
时间窗: 210min
bispectral index monitoring
次要结局
未报告次要终点
研究者
Zhongyuan Xu
Director of GCP Office
Nanfang Hospital, Southern Medical University