Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients
Completed · Not applicable
Conditions studied: Anesthesia
In brief
The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population
Key facts
- Study ID
- NCT04810481
- Run by
- Medtronic - MITG
- People needed
- 209
- Starts
- 2021-07-02
- Expected to finish
- 2022-10-12
- Last updated by the study team
- 2023-04-18
Who can join
Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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 — 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
Full record on ClinicalTrials.gov
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