Clinical trial NCT04810481: Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients
Official title: Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients Undergoing Sevoflurane Anesthesia (BTIGER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 209
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: End-tidal Sevoflurane Concentration
timeFrame: duration of maintenance of anesthesia
Secondary outcomes:
measure: Number of Participants With Each Score on the Wong Baker Faces Scale
timeFrame: up to 4 hours following anesthesia administration
measure: Modified Aldrete Score
timeFrame: up to 4 hours following anesthesia administration
measure: Number of Participants With Reported Airway Reflexes
timeFrame: up to 4 hours following anesthesia administration
measure: Clinical Anesthesia Assessment
timeFrame: up to 4 hours following anesthesia administration
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Newark
country: United States
facility: Rutgers University
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Children's Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: