The Effect of Bispectral Index Monitoring on Recovery From Deep Sedation

The Effect of Bispectral Index Monitoring on the Speed of Recovery From Deep Propofol Sedation in Children With Cerebral Palsy - A Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Cerebral Palsy

Detailed Description

After arrival in the preoperative holding area, children were randomly allocated into two groups using a computer-generated random assignment scheme. Five minutes before propofol sedation, remifentanil is administered intravenously at 0.025 μg / kg / min for analgesic effect and continued throughout the sedation process until just before the end of the procedure. Five minutes after remifentanil administration, 2 mg / kg of propofol mixed with 1 mg / kg of lidocaine was administered over 30 seconds, followed by continuous infusion at 100 μg / kg / min. Group C is monitored using UMSS(University of Michigan Sedation Scale) scores every three minutes, and group B is monitored using BIS score until deep sedation. Deep sedation is defined based on UMSS score of 3-4 and BIS score of 65 ± 5. If the sedation score is determined to have reached a deep sedation, a botulinum toxin injection is given by a practitioner blind to how to assess the depth of sedation. Independent investigator who is blind to group assignement assesses the oxygen saturation, respiration, and blood pressure, recovery time from sedation, and adverse events during and after sedation.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

• Study Contact: Name: Sung Mee Jung, MD,PhD; Phone Number: +82-53-620-3368; Email: applejsm@gmail.com
• Study Contact Backup: Name: Sung Min Jeon, MD; Phone Number: +82-10-9964-0863; Email: sminjun@ynu.ac.kr

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42415
    • Location Yeungnam University Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children with spastic cerebral palsy primary care clinic (rehabilitation)

Description

Inclusion Criteria:

• 3-12 years old children with spastic cerebral palsy receiving botulinum toxin injection with deep sedation
• American Society of Anesthesiologists Physical Status 1-2

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propofol dose	Amount of propofol to maintain deep sedation for botulinum toxin injection	Immediately after discontinuation of propofol infusion used for botulinum toxin injection

Collaborators and Investigators

• Sponsor: Yeungnam University College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 9, 2022
• Study Completion (Actual): December 9, 2022

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Recovery; Cerebral palsy; Deep sedation; Botulinum toxin; Bispectral index monitor
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: YUMC-2019-11-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share our data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No