Prospective, Monocentric Controlled, Randomized, Double-blind Study to Compare the Two Different Propofol Emulsions Regarding Tolerability and Injection Pain During the Induction of Anesthesia in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Expression of Pain During Injection
研究概览
简要总结
The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia.
Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
详细描述
Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults, age ≥ 18 years and ≤ 80 years
- •Anesthetic risk classified as ASA I-III
- •Patients undergoing elective surgery under general anesthesia
- •Signed informed consent
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 active analgesics)
- •Patients taking lipid lowering drugs
- •History of decompensated renal failure
- •History of severe hepatic dysfunction, hepatic cirrhosis
- •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
- •Emergency situation
- •Patient who receives parenteral fat emulsion, e.g. intralipid
- •Patients incapable of giving consent personally
- •Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal
研究组 & 干预措施
1
Modified propofol (Propofol 0.5%)
干预措施: Propofol (Drug)
2
Propofol 1%
干预措施: Propofol 1% (Drug)
结局指标
主要结局
Incidence of Expression of Pain During Injection
时间窗: during first propofol bolus
次要结局
- Further Assessment of Injection Pain(during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia)