Validity of Bispectral Index Monitoring During Deep Sedation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Cerebral Palsy

Clinical Trial Details

NCT number	NCT02096549
Study type	Observational
Source	Yeungnam University College of Medicine
Contact
Status	Completed
Phase
Start date	March 2014
Completion date	April 30, 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.