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

Primary Purpose

Depth of Anaesthesia, EEG, Anesthesia Emergence Delirium

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Sedline EEG sensor placement
Sedline EEG monitoring
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Depth of Anaesthesia

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EEG-Guided Anaesthesia

Routine Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

End tidal sevoflurane concentration at induction
Average sevoflurane concentration (MAC) required during induction
End tidal sevoflurane concentration for maintenance
Average sevoflurane concentration (MAC) required during maintenance

Secondary Outcome Measures

Emergence delirium incidence
Incidence of emergence delirium as measured by the PAED scale
Emergence delirium severity
Severity of emergence delirium as measured by the PAED scale
Post-operative behaviour
Post-operative maladaptive behaviour
Burst Suppression Incidence
Incidence of burst suppression
Burst Suppression Duration
Duration of burst suppression
Burst suppression probability
Burst suppression probability during maintenance, summarized by the mean over the maintenance period
PSI
Patient state index during maintenance of anaesthesia

Full Information

First Posted
August 25, 2019
Last Updated
February 21, 2022
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04103138
Brief Title
EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care
Acronym
EEGPAC
Official Title
EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depth of Anaesthesia, EEG, Anesthesia Emergence Delirium

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
ParticipantOutcomes Assessor
Masking Description
The subject and the outcome assessor analysing the EEG subsequently will be blinded to group allocation.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EEG-Guided Anaesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sedline EEG sensor placement
Intervention Description
Patients will have Sedline EEG sensor placed before or immediately after induction.
Intervention Type
Device
Intervention Name(s)
Sedline EEG monitoring
Intervention Description
Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters
Primary Outcome Measure Information:
Title
End tidal sevoflurane concentration at induction
Description
Average sevoflurane concentration (MAC) required during induction
Time Frame
6 hours: within the intraoperative period
Title
End tidal sevoflurane concentration for maintenance
Description
Average sevoflurane concentration (MAC) required during maintenance
Time Frame
6 hours: within the intraoperative period
Secondary Outcome Measure Information:
Title
Emergence delirium incidence
Description
Incidence of emergence delirium as measured by the PAED scale
Time Frame
Within 3 hours: Postoperative in PACU
Title
Emergence delirium severity
Description
Severity of emergence delirium as measured by the PAED scale
Time Frame
Within 3 hours: Postoperative in PACU
Title
Post-operative behaviour
Description
Post-operative maladaptive behaviour
Time Frame
Within 2 weeks after surgery
Title
Burst Suppression Incidence
Description
Incidence of burst suppression
Time Frame
6 hours: within the intraoperative period
Title
Burst Suppression Duration
Description
Duration of burst suppression
Time Frame
6 hours: within the intraoperative period
Title
Burst suppression probability
Description
Burst suppression probability during maintenance, summarized by the mean over the maintenance period
Time Frame
During maintenance of anaesthesia (up to 4 hours)
Title
PSI
Description
Patient state index during maintenance of anaesthesia
Time Frame
6 hours: within the intraoperative period
Other Pre-specified Outcome Measures:
Title
Mean peak alpha frequency
Description
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;
Time Frame
During maintenance of anaesthesia (up to 4 hours)
Title
Mean peak alpha power
Description
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;
Time Frame
During maintenance of anaesthesia (up to 4 hours)
Title
Mean peak slow oscillation frequency
Description
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;
Time Frame
During maintenance of anaesthesia (up to 4 hours)
Title
Mean peak Slow oscillation power
Description
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.
Time Frame
During maintenance of anaesthesia (up to 4 hours)
Title
Variation in peak alpha frequency
Description
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.
Time Frame
During maintenance of anaesthesia (up to 4 hours)
Title
Variation in peak alpha power
Description
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.
Time Frame
During maintenance of anaesthesia (up to 4 hours)
Title
Phase amplitude modulation depth
Description
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
Time Frame
During maintenance of anaesthesia (up to 4 hours)
Title
Phase amplitude modulation phase
Description
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
Time Frame
During maintenance of anaesthesia (up to 4 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care

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