Elucidating the Neural Correlates of Anesthesia-induced Unconsciousness in Neonates
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 28
SponsorPontificia Universidad Catolica de Chile
About this trial
This study will try to elucidate the neural responses of neonatal patients to surgery-level propofol infusions during induction and maintenance of anesthesia. The main objective is to elucidate the EEG patterns of neural activity that can reliably reflect the level of hypnotic depth in full term neonates undergoing propofol anesthesia based on the classification of EEG into states and the characterization of discrete neonatal EEG events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Full term neonates (37 - 42 weeks of gestational age)
Require general anesthesia/deep sedation during their first 28 days of life because they require a surgery or a specific procedure (cardiac or non-cardiac)
Scheduled for propofol induction
Disqualifiers
Neurological surgeries
Perinatal asphyxia
Evidence of neurological injury or pathology
Suspected brain malformations
Trial population
Patients of the Hospital Clinico UC-Christus.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
64 Participants
are grouped into 1 trial groupGroup A: Main group
Trial outcomes
Primary outcomes
1
Temporal distribution of EEG states
We will evaluate how the temporal distribution of particular EEG states changes across propofol doses. In particular we will evaluate the percentage of time spent by each patient in each EEG state and the transition probabilities between different EEG states during and after propofol induction. EEG states will be defined in two ways: 1. based on peak amplitude of the EEG signal following our previous work (DOI: 10.1097/EJA.0000000000002208) 2. based on data-driven clustering of spectral and non-spectral EEG features. These features will include spectral power in all canonical frequency bands (i.e. slow, delta, theta, alpha and beta bands) as well as entropy/complexity derived measures (e.g. permutation entropy and Lempel-ziv complexity). Each EEG state will be defined. The predictive power of both EEG states defining approach will be evaluated.
Time frame
This will be collected during the anesthesia induction and the first minutes of maintenance of anesthesia2
Distribution of discrete EEG events
We will evaluate how the distribution of EEG events changes across propofol doses. In other words we will quantify the probability of appearance of different EEG events such as k-complexes and delta brushes. The probability of these events will be evaluated as predictors of propofol dosage during and after induction. Time segments with EEG events will be classified as such based on their spectral profiles, which will be evaluated using both classical spectral estimations (multitapers) and also using Empirical Mode Decomposition. The two strategies will be compared.
Time frame
This will be collected during the anesthesia induction and the first minutes of maintenance of anesthesiaSecondary outcomes
1
Severity of illness - nSOFA
We will evaluate severity of illness of each patient using neonatal sequential organ failure assessment (nSOFA) instrument. The instrument scores range from zero to 15 points and higher scores indicate worst status.
Time frame
At the time of surgery2
Severity of illness - NTISS
We will evaluate severity of illness of each patient using the Neonatal therapeutic intervention scoring system (NTISS) instrument. The scores of this instrument typically range from 0 to 47 with higher scores suggesting greater severity of illness. Mean values of 12.3 (SD = 8.7) have been reported for NICU patients)
Time frame
At the time of surgery3
Age
We will evaluate the postnatal and postmenstrual age of patients.
Time frame
At the time of surgeryLocations
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Source ClinicalTrials.gov
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