Validity of Bispectral Index Monitoring During Deep Sedation for Botulinum Toxin Injection in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores
研究概览
简要总结
During Intramuscular botulinum toxin injections for children with cerebral palsy, immobility is essential to inject botulinum toxin to the right muscle. Because children with cerebral palsy are generally unable to control their movement, deep sedation is required during this painful procedure.
Short-acting drugs such as propofol and remifentanil are widely used for pediatric anesthesia and sedation but still have possibility of over-sedation and associated complications due to their rather narrow therapeutic window. Therefore, objective scoring system to assess the level of sedation to provide an effective and safe sedation in children. Bispectral index (BIS) monitoring,an objective guidance of sedation might be helpful.
The present study is to investigate the validity of the BIS monitoring during deep sedation of children with cerebral palsy for injection of botulinum toxin.
详细描述
Intramuscular botulinum toxin injections for children with cerebral palsy have been extensively performed to relive spasticity and improve rehabilitation. During procedure immobility is essential to inject botulinum toxin to the right muscle for optimal effect. Because children with cerebral palsy are generally unable to control their movement, deep sedation is required during this painful procedure.
Short-acting drugs with rapid, predictable onset and offset of action, such as propofol and remifentanil, facilitate infusion rate adjustments and rapid recovery. However, there is always the possibility of over-sedation, hypotension and respiratory depression due to their rather narrow therapeutic window.
Several clinical sedation scales have been used to provide an effective and safe sedation in children. Because clinical scoring depends on patient response to verbal or physical stimulation, it is difficult to assess the level of sedatin in patients with deep sedation during delicate phase of the procedure. Bispectral index (BIS) monitoring,an objective guidance of sedation might be helpful. Although BIS scores in children with conscious and deep sedation were reported to correlate with clinical sedation scales, the validity during painful procedure in children with cerebral palsy was not investigated yet.
The present study is to investigate the validity of the BIS monitoring and its correlation to University of Michigan sedation scale during deep sedation of children with cerebral palsy for injection of botulinum toxin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-II healthy children Ages Eligible for study: 3 to 18 years scheduled for injection of botulinum toxin under deep sedation
排除标准
- •Unstable cardiac disease Recent (< 8 week) pneumonia, bronchitis, asthma attack, respiratory infection Craniofacial defect History of a difficult airway management Hypotonia and lack of head control Tremors
结局指标
主要结局
The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores
时间窗: From induction of sedation to completion of procedure(botulinum toxin injection)
Two independent investigators assessed the level of sedation using the Universtiy of Michigan sedation scale (UMSS) and modified observer's assessment of alertness and sedation (MOAAS) scales every 1 min during the induction of sedation and every 3 min during the maintenance of sedation. The BIS values at each UMSS and MOAAS score were collected. The correlation between the BIS score and UMSS score, and BIS score and MOAAS score was analyzed using the Spearman rank correlation test. The correlation coefficient is expressed as an r-value, and this value is expressed as a single value, not as a range with the lowest and highest values. The higher the value, the better the outcome.
次要结局
未报告次要终点
研究者
Sung Mee Jung
Associate professor in Anesthesiology and Pain Medicine
Yeungnam University College of Medicine