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EEG Monitoring for Anesthetic Depth in Children

N/A
Recruiting
Led By Ian Yuan, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights

Study Summary

This trial monitors anesthetic depth of children under propofol anesthesia using EEG to determine drug amount needed for certain responses.

Who is the study for?
This trial is for children aged 3 to 24 months who need surgery with planned laryngoscopy and propofol anesthesia. They should be generally healthy (ASA < III) without muscle relaxants needed for intubation, not on anti-seizure meds, no known difficult airway or severe neurological issues affecting EEG readings, no allergy to propofol, and have a surgery duration less than approximately 2 hours and 40 minutes.Check my eligibility
What is being tested?
The study tests how well EEG can monitor the depth of anesthesia in infants/toddlers given propofol during surgery. It looks at the EEG spectral edge frequency where half of patients don't react to stimuli like pacifier placement or electrical stimulation while correlating it with blood levels of propofol.See study design
What are the potential side effects?
While this study focuses on monitoring rather than side effects, general risks may include discomfort from the EEG sensor placement on the forehead and potential reactions to stimuli used during monitoring.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EEG SEF50 value for electrical stimulation
EEG SEF50 value for laryngoscopy
EEG SEF50 value for placement of oral pacifier
Secondary outcome measures
Propofol blood concentration at EEG SEF50 for electrical stimulation
Propofol blood concentration at EEG SEF50 for laryngoscopy
Propofol blood concentration at EEG SEF50 for placement of oral pacifier

Trial Design

1Treatment groups
Experimental Treatment
Group I: EEG SEF values in response to stimuliExperimental Treatment1 Intervention
EEG SEF values that correspond to the three stimuli being applied

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,580,909 Total Patients Enrolled
Ian Yuan, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
900 Total Patients Enrolled

Media Library

EEG to Monitor Propofol Anesthetic Depth (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05701748 — N/A
Electroencephalography Spectral Edge Frequency (EEGSEF) Research Study Groups: EEG SEF values in response to stimuli
Electroencephalography Spectral Edge Frequency (EEGSEF) Clinical Trial 2023: EEG to Monitor Propofol Anesthetic Depth Highlights & Side Effects. Trial Name: NCT05701748 — N/A
EEG to Monitor Propofol Anesthetic Depth (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05701748 — N/A

Frequently Asked Questions

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

Does this trial include participants who are of legal age?

"Currently, this trial is seeking infants aged between 3 and 24 months."

Answered by AI

Is enrollment still open to this research endeavor?

"Affirmative. Per the information found on clinicaltrials.gov, this research is presently recruiting participants - it was initially posted on February 3rd 2023 and most recently revised on February 20th of that same year. A total of 75 volunteers are needed from 1 site in order to complete the trial."

Answered by AI

What is the total enrollment of this research trial?

"Affirmative. Records posted on clinicaltrials.gov indicate that this medical trial is actively seeking volunteer participants, having been first announced on the 3rd of February 2023 and last updated on the 20th of February 2021. The study will include 75 individuals from a single centre."

Answered by AI

Who is eligible to participate in this medical research?

"This clinical experiment is open to 75 infants aged 3-24 months who require anesthetic depth. Furthermore, all participants must meet the following prerequisites: undergoing surgery; planned laryngoscopy and endotracheal intubation for medical treatment; propofol anesthesia as part of anesthetic maintenance; ASA rating below III; no muscle relaxing agents indicated during laryngoscopy/intubation; anticipated surgical duration less than 2hr 40minutes."

Answered by AI
~55 spots leftby Dec 2024