Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT05701748
The goal of this study is monitor anesthetic depth of children undergoing propofol anesthesia using electroencephalography (EEG). The main questions it aims to answer are:
1. EEG spectral edge frequency (SEF95) readings where 50% of patients do not respond to three stimuli. 2. The propofol blood concentration that corresponds to each of the three EEG SEF95 readings Participants will undergo EEG monitoring, stimuli (placement of oral pacifier, electrical stimulation, and laryngoscopy), and blood collection.
Looking for future studies?
Notify Me3 month–24 month
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Sevoflurane inhalation and propofol intravenous anesthesia are the mainstays of delivering general anesthesia in children. Propofol anesthesia in children is gaining popularity due to fewer respiratory complications, less post-operative nausea vomiting and emergence delirium, compared to sevoflurane. However, unlike sevoflurane, the pharmacodynamics of propofol is less studied in infants and toddlers, particularly the biomarker for propofol brain effect site concentration (Ce), indicative of anesthetic depth. The lack of a real-time biomarker often results in over- or under-dosing of propofol in clinical practice. The goal of this study is to utilize electroencephalography (EEG) as the biomarker of propofol effect site concentration and clinical anesthetic depth, thereby improving the safety and efficacy of propofol anesthesia in this population. In infants and toddlers receiving propofol anesthesia, EEG will be recorded while the patient undergoes three stimuli used to assess anesthetic depth (placement of oral pacifier, electrical stimulation, and laryngoscopy). The EEG index (spectral edge frequency-SEF95) where 50% of patients (ED50) do not respond to each of the three stimuli will be determined as the biomarker of propofol clinical anesthetic depth. In the same cohort, the regression between EEG SEF95 and plasma propofol levels will be determined to assess relationship between EEG SEF95 and propofol Ce.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
placement of oral pacifier, electrical stimulation, and laryngoscopy
Time frame: Once SEF95 stabilizes at oral pacifier target SEF95 +/- 1Hz for at least one minute
Observation in OR and EEG data analysis
Time frame: Once SEF95 stabilizes at electrical stimulation target SEF95 +/- 1Hz for at least one minute
Observation in OR and EEG data analysis
Time frame: Once SEF95 stabilizes at laryngoscopy target SEF95 +/- 1Hz for at least one minute
Observation in OR and EEG data analysis
Time frame: Once SEF95 stabilizes for at least one minute
Blood collection and testing
Children's Hospital of Philadelphia
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07197567
Anesthetic Depth, General Anesthesia
Sakarya, Adapazari, Turkey (Türkiye)
View Trial Details