N/A Completed N=20

Validity of Bispectral Index Monitoring During Deep Sedation

Source: ClinicalTrials.gov NCT02096549 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcomePrimary: The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores — 0.917; 0.874 correlation coefficient

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores	0.917; 0.874	—

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02096549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.