The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population
This is a multi-center, prospective, observational, non-invasive, randomized controlled study to collect data to compare the performance of standard practice (SP) group with the BIS™ monitoring (BIS) group. Pediatric patients between the ages of 4 to 18 years undergoing routine sevoflurane general anesthesia with an expected surgical procedure duration of greater than 30 minutes will be recruited. If the surgery is less than 15 minutes, the data will continue to be collected, but will not be included in the data analysis and the subject will be replaced with an additional subject. General surgeries including abdominal, urological, orthopedic, or ophthalmological procedures with an American Society of Anesthesiologists physical status of I - III.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
209
The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BIS™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index.
Children's Hospital Colorado
Aurora, Colorado, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Minnesota
Minneapolis, Minnesota, United States
Rutgers University
End-tidal Sevoflurane Concentration
Average end tidal (expired) sevoflurane (ETSevo) concentration during anesthesia maintenance in pediatric patients ages 4 to 18 years. The ETSevo values from each group will be reported to show that the values are different between the BIS group when compared to the Standard Practice Group.
Time frame: duration of maintenance of anesthesia
Number of Participants With Each Score on the Wong Baker Faces Scale
Wong Baker FACES Scale 0-5 with 0 = No Hurt and 5 = Hurt Most
Time frame: up to 4 hours following anesthesia administration
Modified Aldrete Score
The Modified Aldrete Score assesses the readiness of the subject to be discharged from the post anesthesia care unit (PACU) with the higher the number correlating to the more ready a patient is to be discharged, the score range is 0-12.
Time frame: up to 4 hours following anesthesia administration
Number of Participants With Reported Airway Reflexes
Airway reflexes (e.g., coughing, choking, laryngospasm) that are common in anesthesia and not considered adverse events
Time frame: up to 4 hours following anesthesia administration
Clinical Anesthesia Assessment
recorded as the number of events including movement during procedure, eye opening, hypotension, hypertension, tachycardia, bradycardia, and low oxygen saturation (SpO2) that are common in anesthesia and not considered adverse events
Time frame: up to 4 hours following anesthesia administration
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Newark, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
University of Pittsburgh Medical Center, Children's Hospital
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States