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临床试验/NCT04426552
NCT04426552Unknown2 期

Dexmedetomidine Versus Sevoflurane Inhalation for Fibreoptic Nasotracheal Intubation in Children With Anticipated Difficult Intubation

Alexandria University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
40
试验地点
1
主要终点
Assessment of intubation

研究概览

简要总结

difficult problem in the paediatric age group because of their small mouth opening and un-cooperativeness.Currently used methods of sedation for fibreoptic intubation such as benzodiazepines, propofol or opioids may cause respiratory depression, especially when used in high doses

详细描述

Dexmedetomidine, an a2-agonist, has none-to-minimal respiratory depressant effects, which is clearly a great advantage in handling a critical (unstable, difficult) airway while inducing sedation in both adult and infants. The aim is to compare intubation conditions between dexmedetomidine and sevoflurane inhalation during fibreoptic intubation in pediatric patients with an anticipated difficult intubation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
1 Year 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I and II
  • aged 1 year to 3 years
  • require general anaesthesia with tracheal intubation for surgical correction of the congenital or acquired pathology that created the difficult airway

排除标准

  • parents refusal
  • Allergy to drugs

研究组 & 干预措施

Dexmedetomidine

Experimental

have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI

干预措施: dexmedetomidine (Drug)

Sevoflurane

Active Comparator

(sevoflurane) will be preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation

干预措施: sevoflurane (Drug)

结局指标

主要结局

Assessment of intubation

时间窗: At intubation time

as assessed by vocal cord movement

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

rehab zayed

Assisstant Professor of Anesthesia

Alexandria University

研究点 (1)

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