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

NCT04810481 | Completed Results FDA Device

• 1 other identifier: MDT20032BTIGER
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 8

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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Each Score on the Wong Baker Faces Scale

  up to 4 hours following anesthesia administration

• Modified Aldrete Score

  up to 4 hours following anesthesia administration

• Number of Participants With Reported Airway Reflexes

  up to 4 hours following anesthesia administration

• Clinical Anesthesia Assessment

  up to 4 hours following anesthesia administration

Study Arms (2)

Standard Practice

NO INTERVENTION

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

BIS Group

ACTIVE COMPARATOR

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.

Device: BIS Complete Monitoring System

Interventions

BIS Complete Monitoring System DEVICE

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.

BIS Group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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)

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (8)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Rutgers University

Newark, New Jersey, 07103, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

University of Pittsburgh Medical Center, Children's Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Templeton TW, Alex G, Eloy JD, Stollings L, Ing RJ, Cheon EC, Belani K, Breskin I, Sebel PS, Taicher BM; BTiger Study Group. BIS Guided Titration of Sevoflurane in Pediatric Patients Undergoing Elective Surgery: A Randomized Controlled Trial. Paediatr Anaesth. 2025 Apr;35(4):277-286. doi: 10.1111/pan.15057. Epub 2025 Jan 4.

  PMID: 39754470 DERIVED

Results Point of Contact

• Title: Keith Holloman
• Organization: Medtronic

keith.holloman@medtronic.com

6126707136

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Investigator will be blinded to the BIS value in the Standard Practice Group
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 23, 2021
• Study Start: July 2, 2021
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)