跳至主要内容
临床试验/EUCTR2008-005086-55-GB
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

发起方
HS Greater Glasgow & Clyde and University of Glasgow

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