The Effect of Bispectral Index Monitoring on Recovery From Deep Sedation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Palsy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group Control<br>Group who maintains deep sedation using the University of Michigan sedation scale (UMSS) score. | |
| Group BIS<br>Group who maintain deep sedation using Bispectral Index (BIS) score. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recovery, Cerebral palsy, Botulinum toxin, Bispectral index monitor, Deep sedation