Elucidating the Neural Correlates of Anesthesia-induced Unconsciousness in Neonates

NCT07601854 | Not Yet Recruiting

• 2 other identifiers: FONDECYT Iniciacion N°11261085Ethics committee: N°250421014
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia Brain Monitor; Anesthesia; Neonatal Surgery

Keywords

neonatal anesthesia; propofol; brain monitoring; neonatal brain monitoring; neonatal brain states

Outcome Measures

Primary Outcomes (2)

• 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.

  This will be collected during the anesthesia induction and the first minutes of maintenance of anesthesia

• 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.

  This will be collected during the anesthesia induction and the first minutes of maintenance of anesthesia

Secondary Outcomes (3)

• Severity of illness - nSOFA

  At the time of surgery

• Severity of illness - NTISS

  At the time of surgery

• Age

  At the time of surgery

Study Arms (1)

Main group

This main group will consist of neonatal patients that require general anesthesia for a surgery or procedure during their first 28 days of life.

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Hospital Clinico UC-Christus.

You may qualify if:

• 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

You may not qualify if:

• Neurological surgeries
• Perinatal asphyxia
• Evidence of neurological injury or pathology
• Suspected brain malformations
• Patients with metabolic or hemodynamic instability at the time of the surgery or procedure.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Related Publications (3)

• Wynn JL, Polin RA. A neonatal sequential organ failure assessment score predicts mortality to late-onset sepsis in preterm very low birth weight infants. Pediatr Res. 2020 Jul;88(1):85-90. doi: 10.1038/s41390-019-0517-2. Epub 2019 Aug 8.

  PMID: 31394566 BACKGROUND

• Gray JE, Richardson DK, McCormick MC, Workman-Daniels K, Goldmann DA. Neonatal therapeutic intervention scoring system: a therapy-based severity-of-illness index. Pediatrics. 1992 Oct;90(4):561-7.

  PMID: 1408510 BACKGROUND

• Boncompte G, Cortinez LI, Toso A, Giordano A, Cruzat F, Fuentes R, Pedemonte JC, Contreras V, Biggs D, Chiu E, Ibacache M. Differential effects of propofol anaesthesia across three amplitude-defined electroencephalographic states in sedated critically ill term neonates: An observational study. Eur J Anaesthesiol. 2025 Oct 1;42(10):889-898. doi: 10.1097/EJA.0000000000002208. Epub 2025 May 23.

  PMID: 40420743 BACKGROUND

Central Study Contacts

Gonzalo Boncompte, PhD

CONTACT

+569 64319979; gnboncompte@uc.cl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: May 22, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05