EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care (EEGPAC)

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.

Study Overview

• Status: Completed
• Conditions: EEG; Depth of Anaesthesia; Anesthesia Emergence Delirium
• Intervention / Treatment: Device: Sedline EEG sensor placement; Device: Sedline EEG monitoring

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EEG-Guided Anaesthesia; Patients will have Sedline EEG sensor placed and anaesthesia guided by the EEG characteristics, patient state index (PSI) and suppression ratio (SR), in addition to routine clinical parameters.	Device: Sedline EEG sensor placement; Patients will have Sedline EEG sensor placed before or immediately after induction.; Device: Sedline EEG monitoring; Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters
Active Comparator: Routine Care; Patients will have Sedline EEG sensor placed but the monitor is concealed so the clinician is blinded to the EEG response. Anaesthesia is guided by routine clinical parameters.	Device: Sedline EEG sensor placement; Patients will have Sedline EEG sensor placed before or immediately after induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End tidal sevoflurane concentration at induction	Average sevoflurane concentration (MAC) required during induction	6 hours: within the intraoperative period
End tidal sevoflurane concentration for maintenance	Average sevoflurane concentration (MAC) required during maintenance	6 hours: within the intraoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence delirium incidence	Incidence of emergence delirium as measured by the PAED scale	Within 3 hours: Postoperative in PACU
Emergence delirium severity	Severity of emergence delirium as measured by the PAED scale	Within 3 hours: Postoperative in PACU
Post-operative behaviour	Post-operative maladaptive behaviour	Within 2 weeks after surgery
Burst Suppression Incidence	Incidence of burst suppression	6 hours: within the intraoperative period
Burst Suppression Duration	Duration of burst suppression	6 hours: within the intraoperative period
Burst suppression probability	Burst suppression probability during maintenance, summarized by the mean over the maintenance period	During maintenance of anaesthesia (up to 4 hours)
PSI	Patient state index during maintenance of anaesthesia	6 hours: within the intraoperative period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean peak alpha frequency	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;	During maintenance of anaesthesia (up to 4 hours)
Mean peak alpha power	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;	During maintenance of anaesthesia (up to 4 hours)
Mean peak slow oscillation frequency	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;	During maintenance of anaesthesia (up to 4 hours)
Mean peak Slow oscillation power	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.	During maintenance of anaesthesia (up to 4 hours)
Variation in peak alpha frequency	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.	During maintenance of anaesthesia (up to 4 hours)
Variation in peak alpha power	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.	During maintenance of anaesthesia (up to 4 hours)
Phase amplitude modulation depth	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	During maintenance of anaesthesia (up to 4 hours)
Phase amplitude modulation phase	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	During maintenance of anaesthesia (up to 4 hours)

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: August 25, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: CIRB 2019/2235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No