NCT01326078撤回2 期
Comparison Between Propofol Nanoemulsion and Propofol Lipid Emulsion on Children Undergoing Ambulatory Invasive Procedures.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Classification of the sedation level
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of the of propofol nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.
详细描述
Nanoemulsion of propofol has been developed without lipid solvent in the formulation to minimize the adverse events such as pain of injection, redness, heat, phlebitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar Puncture or Myelogram
- •Peripheral Intravenous access available in the veins on the dorsal region of the hand
- •The informed consent signed by the legal responsible of the child allowing the participation in the study
排除标准
- •Relative or absolute contraindications use of propofol and excipients
- •Contraindications to the patient undergo general anesthesia or sedation with drug
- •Allergy derived from egg or soy
- •Use of pre-medication
- •Patient receiving psychotropic drugs
- •Use of opioid within 24 hours
- •The responsible for the children unable to decide for his participation
- •The severity of the condition wich compromises vital functions such as ventilation and hemodynamic balance
- •Liver cancer which compromises its function
- •Changes in the blood tests
- •Others comorbidities in the investigator opinion
研究组 & 干预措施
propofol nanoemulsion
Experimental
3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given.
干预措施: propofol (Drug)
propofol lipid emulsion
Active Comparator
3-4 mg/kg will be administered by 1 ml per 5 seconds.
干预措施: propofol (Drug)
结局指标
主要结局
Classification of the sedation level
时间窗: time 0
Instantly after the loss of consciousness (loss of corneal-palpebral reflex) will be measured the sedation using the Ramsay Modified Scale.
次要结局
- Time of latency(3-10 seconds)
- Pain at injection(3 - 10 seconds: during the injection)
- Physician satisfaction(12 hours: end of procedure)
- Awakening time(10 hours: when the patient awakes)
- Total dose(12 - hours End of procedure)
- Incidence of Adverse Events(0 to 14 hours)
研究者
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