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临床试验/NCT04581213
NCT04581213已完成不适用

Effect of Anesthesia Induction on Cerebral Hemodynamic in Children

St. Justine's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Changes of State Entropy (SE) value during induction

研究概览

简要总结

General anesthesia induces hemodynamic changes, notably a reduction of arterial blood pressure going up to 30%, that may impact cerebral perfusion and oxygenation.The purpose of this study is to assess the impact of anesthesia on the cerebral oxygenation, the perfusion of the brain (assessed with transcranial doppler), and the depth of anesthesia in children between 6 months and 5 years old during the induction of general anesthesia (induced with sevoflurane and/or IV agents). It is expected that the cerebral hemodynamic will be maintained despite systemic variations.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • General anesthesia for elective surgery
  • American Society of Anesthesiologists score 1 and 2
  • Written informed consent obtained from the parents or legal tutors.

排除标准

  • 3 unsuccessful attempts of IV access
  • ultrasound device non available
  • neurologic comorbidity

结局指标

主要结局

Changes of State Entropy (SE) value during induction

时间窗: baseline and 1 minute after intubation

Depth of anesthesia

Changes in NIRS values during induction

时间窗: baseline and 1 minute after intubation

Changes in cerebral Near infra-red spectrometry values

Changes of Response Entropy (RE) value during induction

时间窗: baseline and 1 minute after intubation

Changes in cerebral velocity of the middle cerebral artery during induction

时间窗: baseline and 1 minute after intubation

次要结局

  • Changes of arterial blood pressure during induction(At baseline and 1 minute after intubation)
  • Endtidal Co2 after induction(1 minute after intubation)
  • Changes in NIRS values after induction(At 1 minute, 3 minutes after intubation and at the start of surgery)
  • Changes of State Entropy (SE) value after induction(At 1 minute, 3 minutes after intubation and at the start of surgery)
  • Change in cerebral velocity of the middle cerebral artery after induction(At 1 minute, 3 minutes after intubation and at the start of surgery)
  • Changes of Response Entropy (RE) values after induction(At 1 minute, 3 minutes after intubation and at the start of surgery)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Florent BAUDIN

Principal Investigator

St. Justine's Hospital

研究点 (1)

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