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NCT Number: NCT04103138

EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care

Electroencephalographic recordings (EEG) present an opportunity to monitor changes in human brain electrical activity during changing states of consciousness during general anesthesia.

The investigators aim to determine if EEG-guided anaesthesia using the Masimo Sedline Root monitor will result in different anaesthetic requirements, different anaesthetic depth, and emergence characteristics in children under 16 years of age.

200 children under 16 years undergoing routine general anaesthesia under sevoflurane will be randomized to either EEG monitoring or routine care. We will compare the anaesthetic requirements, the patient state index, number of episodes of burst suppression and the incidence and severity of emergence delrium between the two groups.

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Key information

Conditions

Depth of Anaesthesia Anesthesia Emergence Delirium Confusion Delirium EEG Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

Electroencephalographic recordings (EEG) present an opportunity to monitor changes in human brain electrical activity during changing states of consciousness during general anesthesia.

At present, monitoring of the brain under anaesthesia is not routinely employed. Since every patient is different and the way their brain response to anaesthetic drugs is different, it is important to adjust the patients' anaesthetic depth according to their brains' response, rather than only relying on routine cardiorespiratory parameters. This is important particularly for children, whose physiological responses and electroencephalographic recordings (EEG) differ from that of adults.

200 children under 16 years undergoing routine sevoflurane general anaesthesia will be randomized to either EEG-guided anaesthesia or routine care. The investigators will compare the anaesthetic requirements, the patient state index, number of episodes of burst suppression and the incidence and severity of emergence delrium between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 1-16 years old scheduled to undergo general sevoflurane anaesthesia for surgeries or procedures anticipated to last at between 30 minutes to 4 hours.

Exclusion criteria

  • Patients with neurological diseases including seizure disorders
  • Patients with developmental delay or genetic syndromes
  • Patients with craniofacial deformities where it is not possible to place the EEG sensors
  • Patients with severe eczema or skin allergy or atopy.
  • Patients who are having craniofacial surgery where it is not possible to place the EEG sensors
  • Patients whose foreheads are too small to accommodate the EEG sensors.
  • Patients who require sedative premedications.

Treatment and study plan

Sedline EEG sensor placement

Device

Patients will have Sedline EEG sensor placed before or immediately after induction.

Sedline EEG monitoring

Device

Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters

Primary outcomes

  1. End tidal sevoflurane concentration at induction

    Time frame: 6 hours: within the intraoperative period

    Average sevoflurane concentration (MAC) required during induction

  2. End tidal sevoflurane concentration for maintenance

    Time frame: 6 hours: within the intraoperative period

    Average sevoflurane concentration (MAC) required during maintenance

Secondary outcomes

  1. Emergence delirium incidence

    Time frame: Within 3 hours: Postoperative in PACU

    Incidence of emergence delirium as measured by the PAED scale

  2. Emergence delirium severity

    Time frame: Within 3 hours: Postoperative in PACU

    Severity of emergence delirium as measured by the PAED scale

  3. Post-operative behaviour

    Time frame: Within 2 weeks after surgery

    Post-operative maladaptive behaviour

  4. Burst Suppression Incidence

    Time frame: 6 hours: within the intraoperative period

    Incidence of burst suppression

  5. Burst Suppression Duration

    Time frame: 6 hours: within the intraoperative period

    Duration of burst suppression

  6. Burst suppression probability

    Time frame: During maintenance of anaesthesia (up to 4 hours)

    Burst suppression probability during maintenance, summarized by the mean over the maintenance period

  7. PSI

    Time frame: 6 hours: within the intraoperative period

    Patient state index during maintenance of anaesthesia

Other outcomes

  1. Mean peak alpha frequency

    Time frame: During maintenance of anaesthesia (up to 4 hours)

    Mean peak alpha frequency during maintenance, computed in units of Hz by first searching for the frequency in the alpha band (8 to 12 Hz) that has maximum power in the spectrum, followed by computing the mean over the anesthetic maintenance period, which begins at the start of surgery and ends at the conclusion of the surgical procedure;

  2. Mean peak alpha power

    Time frame: During maintenance of anaesthesia (up to 4 hours)

    Mean peak alpha power during maintenance, computed by calculating the mean power in the alpha band (8 to 12 Hz) in units of decibels (dB) during the anesthetic maintenance period which begins at the start of surgery and ends at the end of the surgical procedure;

  3. Mean peak slow oscillation frequency

    Time frame: During maintenance of anaesthesia (up to 4 hours)

    Mean peak slow oscillation frequency during maintenance, computed in units of Hz by first searching for the frequency in the slowband (0.1-1 Hz) that has maximum power in the spectrum, followed by computing the mean over the anesthetic maintenance period, which begins at the start of surgery and ends at the conclusion of the surgical procedure;

  4. Mean peak Slow oscillation power

    Time frame: During maintenance of anaesthesia (up to 4 hours)

    Mean peak Slow oscillation power during maintenance, computed by calculating the mean power in the slow band (0.1-1Hz) in units of decibels (dB) during the anesthetic maintenance period which begins at the start of surgery and ends at the end of the surgical procedure.

  5. Variation in peak alpha frequency

    Time frame: During maintenance of anaesthesia (up to 4 hours)

    Variation in peak alpha frequency over time during maintenance, computed as the standard deviation of the mean peak alpha frequency, in units of Hz, during the anesthetic maintenance period which begins at the start of surgery and ends at the end of the surgical procedure.

  6. Variation in peak alpha power

    Time frame: During maintenance of anaesthesia (up to 4 hours)

    Variation in peak alpha power over time during maintenance for each patient; computed as the standard deviation of the mean peak alpha power, in units of decibels, during the anesthetic maintenance period which begins at the start of surgery and ends at the end of the surgical procedure.

  7. Phase amplitude modulation depth

    Time frame: During maintenance of anaesthesia (up to 4 hours)

    Phase amplitude modulation depth: The depth of phase amplitude modulation, as defined in Soulat, et al.., 2019, is a dimensionless number between 0 and 1 that describes the extent to which the amplitude of a higher frequency (alpha) oscillation is modulated by a lower frequency (slow) oscillation

    Soulat, H., Stephen, E. P., Beck, A. M., & Purdon, P. L. (2019). State Space Methods for Phase Amplitude Coupling Analysis [Preprint]. Neuroscience. https://doi.org/10.1101/772145

  8. Phase amplitude modulation phase

    Time frame: During maintenance of anaesthesia (up to 4 hours)

    Phase amplitude modulation phase: The modulation phase, as defined in Soulat, et al.., 2019, is the phase, represented as an angle in units of degrees, that describes the lower frequency (slow) phase at which the amplitude of a higher frequency (alpha) oscillation is maximized.

    Soulat, H., Stephen, E. P., Beck, A. M., & Purdon, P. L. (2019). State Space Methods for Phase Amplitude Coupling Analysis [Preprint]. Neuroscience. https://doi.org/10.1101/772145

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Acronym: EEGPAC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2019
Registry last updated
Feb 24, 2022

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.

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