Status:
COMPLETED
Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients
Lead Sponsor:
Medtronic - MITG
Conditions:
Anesthesia
Eligibility:
All Genders
4-18 years
Phase:
NA
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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2022
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT04810481
Start Date
July 2 2021
End Date
October 12 2022
Last Update
April 18 2023
Active Locations (8)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
4
Rutgers University
Newark, New Jersey, United States, 07103