CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02096549
NCT02096549N/ACompleted

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

Yeungnam University College of Medicine·observational·Posted Mar 26, 2014·Updated Jan 30, 2024

In Brief

An observational study for Cerebral Palsy. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCerebral Palsy
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 26, 2014
Enrollment StartMar 1, 2014
Primary CompletionApr 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.3 years ago