Randomised Study of Propofol Versus Placebo for Sedation During Cataract Surgery Under Topical Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of self administered bolus
研究概览
简要总结
Controversies exist about the use of propofol in sedation of patients for cataract surgery. This prospective randomised double-blind study evaluates the efficacy of patient-controlled sedation compared with placebo using the same device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should be operated of cataract under topical anesthesia
排除标准
- •Contra-indication to sedation
- •Complicated cataract
- •Hypersensitivity to propofol, known or suspected hypersensitivity to egg phospholipid, soybean or peanut protein
- •State of acute shock, severe dyslipidemia, severe liver failure, serious bleeding disorders
- •Comprehension and language impairment
- •Written and signed informed consent by the patient to participate in the study
研究组 & 干预措施
Propofol
Infusion containing Propofol lipuro® 2% at a concentration of 2 mg/ml (100 ml of 5% glucose at which is removed 20 ml replaced with 20 ml of Propofol lipuro® 2 %).
Self administration of propofol via patient-controlled sedation pump (ambIT pump) : bolus of 0.125 ml/kg of the solution (0.25 mg/kg propofol) with a programmed lock-out period of 3 minutes.
Maximal dose of propofol : 1,25 mg/kg corresponding to 5mg/kg/h.
干预措施: Propofol (Drug)
Intralipid
Infusion containing Intralipid® (100 ml of 5% glucose at which is removed 20 ml replaced with 20 ml of Intralipid® 20%) to obtain an identical aspect to that of propofol infusion.
Self administration via patient-controlled sedation pump (ambIT pump) : bolus of 0.125 ml/kg of the solution with a programmed lock-out period of 3 minutes.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of self administered bolus
时间窗: One day
次要结局
未报告次要终点