Trial Outcomes & Findings for Validity of Bispectral Index Monitoring During Deep Sedation (NCT NCT02096549)
NCT ID: NCT02096549
Last Updated: 2024-01-30
Results Overview
Two independent investigators assessed the level of sedation using the Universtiy of Michigan sedation scale (UMSS) and modified observer's assessment of alertness and sedation (MOAAS) scales every 1 min during the induction of sedation and every 3 min during the maintenance of sedation. The BIS values at each UMSS and MOAAS score were collected. The correlation between the BIS score and UMSS score, and BIS score and MOAAS score was analyzed using the Spearman rank correlation test. The correlation coefficient is expressed as an r-value, and this value is expressed as a single value, not as a range with the lowest and highest values. The higher the value, the better the outcome.
COMPLETED
20 participants
From induction of sedation to completion of procedure(botulinum toxin injection)
2024-01-30
Participant Flow
This study was conducted at Yeungnam Univerisity Hospital in South korea from March 2014 to April 2017. Twenty children with spastic CP, with an American Society of Anesthesiologists physical status of 1 and 2, aged between 3 and 18 years, who were scheduled for a botulinum toxin injection under deep sedation, were enrolled.
This prospective observational study was approved by the Institutional Review Board (YUH-14-0319-O10) and was registered with ClinicalTrials.gov (NCT02096549) on March 28, 2014. Written informed consent from the participants' parents and, when appropriate, verbal assent from the participating children were obtained before enrollment in the study.
Participant milestones
| Measure |
Children With Spastic Cerebral Palsy
children with spastic CP, with an American Society of Anesthesiologists physical status of 1 and 2, aged between 3 and 18 years, who were scheduled for a botulinum toxin injection under deep sedation, were enrolled. Children were excluded from the study if they had an anticipated difficult airway, unstable cardiac disease, craniofacial defect, allergy to drugs used in this study, and/or history of recent (\< 8 weeks) pneumonia, bronchitis, asthma attack, or an upper respiratory infection.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validity of Bispectral Index Monitoring During Deep Sedation
Baseline characteristics by cohort
| Measure |
Spastic Cerebral Palsy
n=22 Participants
After confirmation of adequate spontaneous respiration 5 minutes after remifentanil infusion in children, an attending anesthesiologist administered propofol (1.5 mg/kg) mixed with lidocaine (1 mg/kg) over 1 minute followed by continuous infusion of propofol on the basis of clinical signs of arousability, movement, blood pressure, heart rate and respiratory rate. Two independent investigators, who were blinded to BIS values, assessed the level of sedation using the UMSS scores every minute from baseline to induction of deep sedation. BIS values measured immediately before stimulation for assessing the UMSS observation were collected by another independent investigator. The BIS value with a signal quality index (SQI) ≥ 50 was accepted for analysis. Spearman rank order correlation analysis was used to evaluate the relationship of BIS and UMSS. The cut-off BIS value for detecting deep sedation was determined by analysis of receiver-operating characteristic (ROC) curve. The area under the
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Age, Continuous
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10.5 years
STANDARD_DEVIATION 5.3 • n=99 Participants
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Sex: Female, Male
sex · Female
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7 Participants
n=99 Participants
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Sex: Female, Male
sex · Male
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15 Participants
n=99 Participants
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Race/Ethnicity, Customized
Asian
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20 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: From induction of sedation to completion of procedure(botulinum toxin injection)Population: Children with spastic Cerebral Palsy undergoing botulinum toxin injection
Two independent investigators assessed the level of sedation using the Universtiy of Michigan sedation scale (UMSS) and modified observer's assessment of alertness and sedation (MOAAS) scales every 1 min during the induction of sedation and every 3 min during the maintenance of sedation. The BIS values at each UMSS and MOAAS score were collected. The correlation between the BIS score and UMSS score, and BIS score and MOAAS score was analyzed using the Spearman rank correlation test. The correlation coefficient is expressed as an r-value, and this value is expressed as a single value, not as a range with the lowest and highest values. The higher the value, the better the outcome.
Outcome measures
| Measure |
Children With Spastic Cerebral Palsy
n=20 Participants
Children with spastic CP, with an American Society of Anesthesiologists physical status of 1 and 2, aged between 3 and 18 years, who were scheduled for a botulinum toxin injection under deep sedation, were enrolled. Children were excluded from the study if they had an anticipated difficult airway, unstable cardiac disease, craniofacial defect, allergy to drugs used in this study, and/or history of recent (\< 8 weeks) pneumonia, bronchitis, asthma attack, or an upper respiratory infection.
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The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores
correlation of the UMSS score and BIS value
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0.917 correlation coefficient
Interval 0.858 to 0.969
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The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores
Correlation for the MOAAS score and BIS value
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0.874 correlation coefficient
Interval 0.808 to 0.94
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Adverse Events
Validity of Bispectral Index Monitoring
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sung Mee Jung, M.D
Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Daegu, Republic of Korea
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place