Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients

Not Applicable

Completed

Brief Summary: The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Pediatric Subjects (ASA physical status I or II or III) aged: 4 years to 18 years scheduled for procedures with sedation where the process of assessment will not interfere with the procedure, progress, or patient care

Exclusion Criteria

Has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes, or other medical sensors
Known neurological disorder (e.g., epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma, hemiplegia, demyelinating disorders, cerebral palsy, congenital anomalies of the brain or spinal cord, or other known neurologic disorders)
Severe developmental delay per assessment of investigator or report of parent/guardian
Airway abnormalities
Pregnancy; subjects of childbearing potential will have a urine screen for pregnancy before surgery
If the process of assessment will interfere with the procedure or the progress of the procedure
Taking psychoactive medications
Taking any medications that may have an impact on the Central Nervous System (CNS)
Planned use of any regional anesthesia; a local field block is not included in this exclusion and can be used at the discretion of the anesthesia provider

Arm && Interventions

Group	Intervention	Description
BIS Group	BIS Complete Monitoring System	Anesthesia will be titrated to achieve a BIS value of 45-60 during maintenance of anesthesia. Additional intervention will be provided only if the subject is in distress.

Primary Outcome Measures

Name	Time	Method
End-tidal Sevoflurane Concentration	duration of maintenance of anesthesia	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Each Score on the Wong Baker Faces Scale	up to 4 hours following anesthesia administration	Wong Baker FACES Scale 0-5 with 0 = No Hurt and 5 = Hurt Most
Modified Aldrete Score	up to 4 hours following anesthesia administration	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.
Number of Participants With Reported Airway Reflexes	up to 4 hours following anesthesia administration	Airway reflexes (e.g., coughing, choking, laryngospasm) that are common in anesthesia and not considered adverse events
Clinical Anesthesia Assessment	up to 4 hours following anesthesia administration	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

Locations (8): Rutgers University
🇺🇸
Newark, New Jersey, United States
Lurie Children's Hospital of Chicago
🇺🇸
Chicago, Illinois, United States
University of Pittsburgh Medical Center, Children's Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
Children's Hospital Colorado
🇺🇸
Aurora, Colorado, United States
Atrium Health Wake Forest Baptist
🇺🇸
Winston-Salem, North Carolina, United States