Bispectral Index as a Guide for Titration of Propofol During Procedural Sedation Among Children

To determine whether the bispectral index (BIS) monitor could be used to guide physicians in titrating propofol to an effective safe level of deep sedation for children undergoing painful medical procedures. Multiphase clinical trial. Outpatient treatment center of a university children's hospi...

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Bibliographic Details
Published in:Pediatrics (Evanston) 2005-06, Vol.115 (6), p.1666-1674
Main Authors: Powers, Karen S, Nazarian, Emily B, Tapyrik, Sarah A, Kohli, Susan M, Yin, Hsiang, van der Jagt, Elise W, Sullivan, John S, Rubenstein, Jeffrey S
Format: Article
Language:English
Subjects:
Adolescent
Adult
Algorithms
Anxiety - prevention & control
Biological and medical sciences
Care and treatment
Catheterization
Child
Child, Preschool
Clinical outcomes
Clinical trials
Consciousness - drug effects
Device Removal
Diagnostic Tests, Routine
Dose-Response Relationship, Drug
Electroencephalography - drug effects
Endoscopy
Female
General aspects
Hemodynamics - drug effects
Hospitals, University - statistics & numerical data
Humans
Hypnotics and Sedatives - administration & dosage
Hypnotics and Sedatives - pharmacology
Infant
Infant, Newborn
Male
Medical procedures
Medical sciences
Medical treatment
Monitoring, Physiologic - instrumentation
Monitoring, Physiologic - methods
Outpatient Clinics, Hospital - statistics & numerical data
Pain - etiology
Pain - prevention & control
Pain in children
Pediatric pain
Pediatrics
Propofol
Propofol - administration & dosage
Propofol - pharmacology
Volumetric analysis
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Summary:To determine whether the bispectral index (BIS) monitor could be used to guide physicians in titrating propofol to an effective safe level of deep sedation for children undergoing painful medical procedures. Multiphase clinical trial. Outpatient treatment center of a university children's hospital. Pediatric outpatients undergoing painful medical procedures. Patients were sedated with propofol for the procedures. Patients were monitored with a BIS monitor, and the BIS score was correlated with the patient's clinical level of sedation. The BIS score was then used as a guide to titrate propofol in the last phase of the study. The study consisted of 3 phases. In a chart review of data for 154 children who underwent 212 procedures, propofol was found to be safe and effective, with consistent dosing among the intensivists administering the medication. The children received a mean bolus dose of propofol of 1.56 mg/kg, with a mean total dose of propofol of 0.33 mg/kg per minute for the duration of the procedure. In the second phase, 21 patients ranging in age from 27 weeks to 18 years, with normal neurologic function, were sedated with propofol. An observer who was blinded to the BIS scores recorded clinical levels of sedation and reactivity (with a modified Ramsay scale and reactivity score) every 1 to 3 minutes. Another observer recorded the BIS scores at the same times. A total of 275 data points were collected and evaluated. All data points from the times at which patients were considered to be sedated adequately were used to construct a normal distribution of BIS scores. The mean BIS score was 62. This distribution was used to predict that a maximal BIS score of 47 was needed to ensure adequate sedation for 90% of the population. In the third phase of the study, an algorithm was devised to determine the target BIS score necessary for adequate sedation of 95% of the patients. We chose an initial BIS score of 50 (at which 85% of the patients in phase 2 were sedated) because of the possibility of data from phase 2 being skewed toward oversedation. Propofol was administered by an intensivist in an attempt to maintain the target BIS score. A blinded observer noted the patient's clinical level of sedation. In this group, there were 2 failures, ie, patients were clinically uncomfortable despite a BIS score of < or =50, representing only 90% success. Therefore, with the algorithm, propofol was titrated to sedate the next patients to a BIS score of 45. These patients
ISSN:0031-4005
1098-4275
DOI:10.1542/peds.2004-1979