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BIS Group for Anesthesia (BTIGER Trial)

N/A
Waitlist Available
Research Sponsored by Medtronic - MITG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 hours following anesthesia administration
Awards & highlights

BTIGER Trial Summary

This trial looks at how well different anesthetics work in kids, based on how they affect the brain.

BTIGER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

BTIGER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of maintenance of anesthesia
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of maintenance of anesthesia for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
End-tidal Sevoflurane Concentration
Secondary outcome measures
Clinical Anesthesia Assessment
Modified Aldrete Score
Number of Participants With Each Score on the Wong Baker Faces Scale
+1 more

BTIGER Trial Design

2Treatment groups
Active Control
Group I: BIS GroupActive Control1 Intervention
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.
Group II: Standard PracticeActive Control1 Intervention
Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.

Find a Location

Who is running the clinical trial?

Medtronic - MITGLead Sponsor
252 Previous Clinical Trials
300,477 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients
2021. "Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04810481.
~56 spots leftby Apr 2025
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