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临床试验/NCT03553446
NCT03553446已完成不适用

50% Effective Concentration of Sevoflurane for Immobility in Cerebral Palsy Children Undergoing Botulinum Toxin Injection

Yeungnam University College of Medicine1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年7月29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
状态
已完成
入组人数
23
试验地点
1
主要终点
the incidence of immobility

研究概览

简要总结

Sevoflurane is as attractive inhalation agent fore deep sedation in children undergoing short invasive procedure because of lack of irritation to the respiratory tract, a pleasant odor and rapid clinical effect and recovery due to low blood gas partition coefficient.

The aim of this study is to determine the optimum inspired concentration of sevoflurane required for immobility during botulinum toxin injection in spontaneously breathing children with cerebral palsy.

详细描述

All anesthetics were administered by a single experienced anesthesiologist. Anesthetic induction was performed progressively with inhaled 1-8% sevoflurane, if the patient was cooperative, otherwise directly to the 8%, and subsequent maintenance 2% in oxygen at 5 L /min. A face mask was connected to a Mapleson C circuit for it. Patients breathed spontaneously, unaided, via a pediatric face mask. A failure was defined as the patient continued to move after following the study protocol for sevoflurane inhalation. Insufficient sedation was treated with increments of 0.5% concentration to achieve the desired effect, ie, maintenance of immobility during botulinum toxin injection. The sevoflurane concentration in the next patient would be adjusted depending on the success or failure for immobility at given sevoflurane concentration ( if successful, 0.5% lower concentration, if failed, 0.5% higher concentration).

The child was recovered from sevoflurane sedation at the end of botulinum toxin injection and transferred to post-anesthetic care unit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 3-12 years old children with cerebral palsy receiving sevoflurane inhalation for botulinum toxin injection
  • American society of anesthesiologists Physical status 1-2

排除标准

  • Body mass index > 30 kg/m2
  • unstable heart disease
  • Anticipated difficult airway history including congenital facial or airway anomaly
  • Recent upper respiratory tract infection ( < 2 weeks)
  • Gastroesophageal reflux
  • Allergy history to sevoflurane, remifentanil or any drug used during procedure

研究组 & 干预措施

children receiving sevoflurane

Experimental

Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method

干预措施: children receiving sevoflurane (Drug)

结局指标

主要结局

the incidence of immobility

时间窗: during procedure (Botulinum injection)

cerebral palsy child who maintains immobility during botulinum toxin injection

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

Sung Mee Jung

Professor

Yeungnam University College of Medicine

研究点 (1)

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