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Validity of Bispectral Index Monitoring During Deep Sedation

NCT02096549 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-01-30

Study results available
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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.

Conditions

  • Cerebral Palsy

Sponsors & Collaborators

  • Yeungnam University College of Medicine

    lead OTHER

Principal Investigators

  • Duk Hee Lee, M.D. · Yeungnam University Hospital

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096549 on ClinicalTrials.gov