EUCTR2008-005086-55-GB进行中(未招募)1 期
Evaluation of propofol TCI anaesthesia in infants age 6m-3y. - Propofol TCI in infants
HS Greater Glasgow & Clyde and University of Glasgow0 个研究点目标入组 50 人开始时间: 2008年10月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
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
入选标准
- •Healthy male and female children aged 6m-3y (inclusive)
- •Weight 7-16kg
- •Elective surgery of expected duration > /=30 minutes
- •ASA Grade 1 or 2
- •Written informed consent from parent
- •Child suitable for intravenous induction and maintenance of anaesthesia with propofol
- •Children with no contraindication to application of local anaesthetic cream or gel to the cannulation site for intravenous induction
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age < 6m or >3y (>36m)
- •Weight < 7kg or >/=17kg
- •Children undergoing urgent or emergency surgical procedures
- •Expected duration of surgery < 30 minutes
- •ASA Grade 3-5
- •No written informed consent from parent
- •Children with difficult venous access
- •Children who need or wish inhalational induction
- •Children who will need intermittent positive pressure ventilation along with the use of muscle relaxant
- •Patients who need sedative premedication
- •Propofol contraindicated (allergy to propofol or its formula components)
- •Local anaesthetic cream or gel contraindicated
研究者
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