50% Effective Concentration of Sevoflurane for Immobility in Cerebral Palsy Children Undergoing Botulinum Toxin Injection
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
- 否
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
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
Sung Mee Jung
Professor
Yeungnam University College of Medicine
