Cerebral Palsy
Conditions
Keywords
cerebral palsy, Botulinum toxin, Propofol, Deep sedation, Bispectral index monitor
Brief summary
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
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.
Interventions
None listed
Sponsors
Yeungnam University College of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores | 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. |
Countries
South Korea
Participant flow
Recruitment details
This study was conducted at Yeungnam Univerisity Hospital in South korea from March 2014 to April 2017. Twenty children with spastic CP, with an American Society of Anesthesiologists physical status of 1 and 2, aged between 3 and 18 years, who were scheduled for a botulinum toxin injection under deep sedation, were enrolled.
Pre-assignment details
This prospective observational study was approved by the Institutional Review Board (YUH-14-0319-O10) and was registered with ClinicalTrials.gov (NCT02096549) on March 28, 2014. Written informed consent from the participants' parents and, when appropriate, verbal assent from the participating children were obtained before enrollment in the study.
Participants by arm
| Arm | Count |
|---|---|
| Spastic Cerebral Palsy After confirmation of adequate spontaneous respiration 5 minutes after remifentanil infusion in children, an attending anesthesiologist administered propofol (1.5 mg/kg) mixed with lidocaine (1 mg/kg) over 1 minute followed by continuous infusion of propofol on the basis of clinical signs of arousability, movement, blood pressure, heart rate and respiratory rate. Two independent investigators, who were blinded to BIS values, assessed the level of sedation using the UMSS scores every minute from baseline to induction of deep sedation. BIS values measured immediately before stimulation for assessing the UMSS observation were collected by another independent investigator. The BIS value with a signal quality index (SQI) ≥ 50 was accepted for analysis. Spearman rank order correlation analysis was used to evaluate the relationship of BIS and UMSS. The cut-off BIS value for detecting deep sedation was determined by analysis of receiver-operating characteristic (ROC) curve. The area under the | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Spastic Cerebral Palsy |
|---|---|
| Age, Continuous | 10.5 years STANDARD_DEVIATION 5.3 |
| Race/Ethnicity, Customized Asian | 20 Participants |
| Sex: Female, Male sex Female | 7 Participants |
| Sex: Female, Male sex Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores
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.
Time frame: From induction of sedation to completion of procedure(botulinum toxin injection)
Population: Children with spastic Cerebral Palsy undergoing botulinum toxin injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children With Spastic Cerebral Palsy | The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores | correlation of the UMSS score and BIS value | 0.917 correlation coefficient |
| Children With Spastic Cerebral Palsy | The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores | Correlation for the MOAAS score and BIS value | 0.874 correlation coefficient |