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临床试验/NCT04598061
NCT04598061Unknown不适用

IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2020年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
210
试验地点
1
主要终点
duration of motor block

研究概览

简要总结

  • Spinal anesthesia in newborns is one of " Gold standard " techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia.
  • Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child's movements and certain degrees of discomfort may also interfere with the successful completion of the procedure.
  • The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery
  • Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist.
  • Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child's comfort and allows the procedure to be performed under optimal conditions for practitionner.
  • The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery

Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery

干预措施: Dexmedetomidine IV (Drug)

结局指标

主要结局

duration of motor block

时间窗: immediately after procedure in the recovery room

Time at which the motor block is finished

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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