The Effect of Bispectral Index Monitoring on Recovery From Deep Sedation

NCT04190082 | Terminated DMC

• 1 other identifier: YUMC-2019-11-001
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare BIS (bispectral index) monitoring and clinical sedation scale assessment on the recovery time and propofol usage from deep propofol sedation in children with cerebral palsy who received botulinum toxin injection.

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; Botulinum toxin; Bispectral index monitor; Deep sedation; Recovery

Outcome Measures

Primary Outcomes (1)

• recovery

  Time taken to recover based on the Physiological CBD score (\>12) from deep sedation

  Immediately after discontinuation of propofol infusion used for botulinum toxin injection

Secondary Outcomes (1)

• Propofol dose

  Immediately after discontinuation of propofol infusion used for botulinum toxin injection

Study Arms (2)

Group Control

Group who maintains deep sedation using the University of Michigan sedation scale (UMSS) score.

Group BIS

Group who maintain deep sedation using Bispectral Index (BIS) score.

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children with spastic cerebral palsy primary care clinic (rehabilitation)

You may qualify if:

• years old children with spastic cerebral palsy receiving botulinum toxin injection with deep sedation
• American Society of Anesthesiologists Physical Status 1-2

You may not qualify if:

• Body mass index \> 30 kg/m2
• unstable heart disease
• Anticipated difficult airway including congenital facial or airway anomaly
• Recent upper respiratory tract infection ( \< 2 weeks)
• Gastroesophageal reflux
• Allergy history to propofol, remifentanil or any drug used during procedure

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Location Yeungnam University Hospita

Daegu, 42415, South Korea

Location

Related Publications (3)

• Choudhry DK, Brenn BR. Bispectral index monitoring: a comparison between normal children and children with quadriplegic cerebral palsy. Anesth Analg. 2002 Dec;95(6):1582-5, table of contents. doi: 10.1097/00000539-200212000-00020.

  PMID: 12456420 RESULT

• Malviya S, Voepel-Lewis T, Tait AR. A comparison of observational and objective measures to differentiate depth of sedation in children from birth to 18 years of age. Anesth Analg. 2006 Feb;102(2):389-94. doi: 10.1213/01.ANE.0000184045.01780.73.

  PMID: 16428530 RESULT

• Saricaoglu F, Celebi N, Celik M, Aypar U. The evaluation of propofol dosage for anesthesia induction in children with cerebral palsy with bispectral index (BIS) monitoring. Paediatr Anaesth. 2005 Dec;15(12):1048-52. doi: 10.1111/j.1460-9592.2005.01658.x.

  PMID: 16324022 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Sung Mee Jung, MD,PhD

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 9, 2019
• Study Start: May 1, 2021
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)