Validity of Bispectral Index Monitoring During Deep Sedation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Validity of Bispectral Index Monitoring During Deep Sedation for Botulinum Toxin Injection in Children With Cerebral Palsy

Conditions
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Cerebral Palsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bispectral index score at deep sedation after injection of propofol | deep sedation is defined by a depression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated verbal or painful stimulation (e.g., purposefully pushing away the noxious stimuli). | baseline(on arrival in operating room), 15 seconds after achivement of deep sedation ( University of Michigan sedation scale (UMSS) 4) after injection of propofol( | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| purposeful withdrawal in response to significant physical stimulation (Trapezius squeeze) | deep sedation is defined by a depression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated verbal or painful stimulation (e.g., purposefully pushing away the noxious stimuli). | up to 10 min after injection of propofol | 
| Oxygen saturation (sPO2(%)) | 1deep sedation is defined by a depression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated verbal or painful stimulation (e.g., purposefully pushing away the noxious stimuli). | up to 10 min after injection of propofol | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum toxin, Propofol, Deep sedation, Bispectral index monitor, cerebral palsy