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

Anesthesia Clinical Trial

— BTIGER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810481
• Other study ID #: MDT20032BTIGER
• Status: Completed
• Phase: N/A
• Start date: July 2, 2021
• Est. completion date: October 12, 2022

Study information

• Verified date: March 2023
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• BIS Complete Monitoring System
The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BIS™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

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