N/A
N=20
Validity of Bispectral Index Monitoring During Deep Sedation
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT02096549 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores — 0.917; 0.874 correlation coefficient
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Yeungnam University College of Medicine
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores |
0.917; 0.874 | — |
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.
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
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.