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

Medtronic

Status: Completed

Conditions: Anesthesia

Treatments: Device: BIS Complete Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04810481

MDT20032BTIGER

Details and patient eligibility

About

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

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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209 participants in 2 patient groups

Standard Practice

No Intervention group

Description:

Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.

BIS Group

Active Comparator group

Description:

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.

Treatment:

Device: BIS Complete Monitoring System