EUCTR2007-003571-39-DE进行中（未招募）不适用
Prospective, monocentric, controlled, randomized, double-blind study to comparetwo different propofol emulsions regarding tolerability and injection pain during the induction of anesthesia in adults
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female adults, age = 18 years and = 80 years
- •Anaesthetic risk classified as ASA I-III
- •Patients undergoing elective surgery under general anesthesia
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Simultaneous participation in another trial
- •Known or suspected drug abuse
- •Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other necessary co-medication
- •Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or centrally acitive analgesics)
- •Patients taking lipid lowering drugs
- •History of severe hepatic dysfunction, hepatic cirrhosis
- •History of decompensated renal failure
- •Angiographically confirmed CHD (coronary heart disease) or cerebral ischemia
- •History of convulsive disorders
- •Decompensated cardiac insufficiency
- •Hypovolemia
- •Increased intracranial pressure
- •Pregnancy (positive ß-HCG test) and lactation
- •Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal
- •Emergency situation
- •Patient who receives parenteral fat emulsion, e.g. intralipid
- •Patients incapable of giving consent personally
研究者
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