An observational study in Cerebral Palsy, sponsored by Yeungnam University College of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Yeungnam University College of Medicine · Observational
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.
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 20 is below the median of 63 across 472 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Yeungnam University College of Medicine is the lead sponsor of 32 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
primary care clinic (rehabilitation)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
| Milestone | Children With Spastic Cerebral Palsy |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| correlation coefficient | Children With Spastic Cerebral Palsy |
|---|---|
| correlation of the UMSS score and BIS value | 0.917 (0.858 to 0.969) |
| Correlation for the MOAAS score and BIS value | 0.874 (0.808 to 0.940) |
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Validity of Bispectral Index Monitoring | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
22 children with cerebral palsy
| Age, Continuous(years) | Spastic Cerebral Palsy |
|---|---|
| Mean | 10.5 ± 5.3 |
| Sex: Female, Male(Participants) | Spastic Cerebral Palsy |
|---|---|
| sex — Female | 7 |
| sex — Male | 15 |
| Race/Ethnicity, Customized(Participants) | Spastic Cerebral Palsy |
|---|---|
| Asian | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — no plan to share our data
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yeungnam University College of Medicine