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临床试验/EUCTR2013-002122-23-NL
EUCTR2013-002122-23-NL进行中(未招募)不适用

The influence of electroencephalographic Narcotrend Index™- guidance of of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in paediatric patients - NI-PPS

Erasmus University Medical Center0 个研究点开始时间: 2013年7月10日最近更新:
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相关药物

试验速览

阶段
不适用
状态
进行中(未招募)

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

性别
All

入选标准

  • Written informed consent of patients and their parents/legal representatives • Age 12-17 years • Bodyweight = 60 kg • Gastrointestinal endoscopy • Eligibility for procedural sedation • Ability of the patient to communicate in Dutch
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 40
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range 0
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Withdrawal of informed consent • Chronic exposure (more than one day) to psychotropic drugs and/or opioids • Known allergy/intolerance for propofol and/or remifentanil • Anticipated difficult airway • Child not eligible for procedural sedation, need for inhalation induction and general anaesthesia • Patient and/or parents unable to communicate in Dutch Secondary exclusion criteria • Unexpected need for inhalation induction of general anaesthesia due to major difficulties to obtain intravenous access. • Unexpected procedural events requiring endotracheal intubation

研究者

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