Anesthesia Clinical Trial
— BTIGEROfficial title:
Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients Undergoing Sevoflurane Anesthesia (BTIGER)
Verified date | March 2023 |
Source | Medtronic - MITG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population
Status | Completed |
Enrollment | 209 |
Est. completion date | October 12, 2022 |
Est. primary completion date | October 12, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 18 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Lurie Children's Hospital of Chicago | Chicago | Illinois |
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 | Rutgers University | Newark | New Jersey |
United States | University of Pittsburgh Medical Center, Children's Hospital | Pittsburgh | Pennsylvania |
United States | Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | End-tidal Sevoflurane Concentration | 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. | duration of maintenance of anesthesia | |
Secondary | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale 0-5 with 0 = No Hurt and 5 = Hurt Most | up to 4 hours following anesthesia administration | |
Secondary | Modified Aldrete Score | 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. | up to 4 hours following anesthesia administration | |
Secondary | Number of Participants With Reported Airway Reflexes | Airway reflexes (e.g., coughing, choking, laryngospasm) that are common in anesthesia and not considered adverse events | up to 4 hours following anesthesia administration | |
Secondary | Clinical Anesthesia Assessment | 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 | up to 4 hours following anesthesia administration |
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