Validity of Bispectral Index Monitoring During Deep Sedation

NCT02096549 | Completed Results DMC

• 1 other identifier: YUH-14-0319-O10
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cerebral palsy; Botulinum toxin; Propofol; Deep sedation; Bispectral index monitor

Outcome Measures

Primary Outcomes (1)

• The Correlation Between the Paired BIS Value Categories and Clinical Sedation Scores

  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.

  From induction of sedation to completion of procedure(botulinum toxin injection)

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic (rehabilitation)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam University Hospital

Daegu, 705-717, South Korea

Location

Related Publications (3)

• McDermott NB, VanSickle T, Motas D, Friesen RH. Validation of the bispectral index monitor during conscious and deep sedation in children. Anesth Analg. 2003 Jul;97(1):39-43, table of contents. doi: 10.1213/01.ane.0000067402.02136.a2.

  PMID: 12818940 BACKGROUND

• Soudant DL, Staal HM, Witlox AM, Vles JS. Conscious sedation or general anaesthetic for intramuscular botulinum toxin injections in children - a two centre cross-sectional prospective audit. Eur J Paediatr Neurol. 2013 Mar;17(2):219-20. doi: 10.1016/j.ejpn.2012.06.012. Epub 2012 Aug 4. No abstract available.

  PMID: 22871256 BACKGROUND

• American Academy of Pediatrics; American Academy of Pediatric Dentistry; Cote CJ, Wilson S; Work Group on Sedation. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update. Paediatr Anaesth. 2008 Jan;18(1):9-10. doi: 10.1111/j.1460-9592.2007.02404.x. No abstract available.

  PMID: 18095958 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

This study has some limitations. We couldn't identify the age-related correlations among the CP children undergoing botulinum toxin injection and we did not know the correlation with BIS scores and UMSS and MOAAS scores according to sex.

Results Point of Contact

• Title: Sung Mee Jung, M.D
• Organization: Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Daegu, Republic of Korea

applejsm@gmail.com

+82-53-620-3368

Study Officials

• Duk Hee Lee, M.D.

  Yeungnam University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor in Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 26, 2014
• Study Start: March 1, 2014
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)