The Effect of Bispectral Index Monitoring on Recovery From Deep Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-12-09

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.

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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.

Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group Control

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

No interventions assigned to this group

Group BIS

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

No interventions assigned to this group

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No