Clinical trial NCT04190082: The Effect of Bispectral Index Monitoring on Recovery From Deep Sedation
Official title: The Effect of Bispectral Index Monitoring on the Speed of Recovery From Deep Propofol Sedation in Children With Cerebral Palsy - A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Botulinum toxin
Bispectral index monitor
Deep sedation
Recovery
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with spastic cerebral palsy primary care clinic (rehabilitation)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: recovery
timeFrame: Immediately after discontinuation of propofol infusion used for botulinum toxin injection
Secondary outcomes:
measure: Propofol dose
timeFrame: Immediately after discontinuation of propofol infusion used for botulinum toxin injection
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Location Yeungnam University Hospita
Study officials:
affiliation: Yeungnam University Hospital
name: Sung Mee Jung, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.