NCT04103138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

September 26, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

February 24, 2022

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

August 25, 2019

Last Update Submit

February 21, 2022

Conditions

Depth of AnaesthesiaEEGAnesthesia Emergence Delirium

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Emergence delirium incidence

    Within 3 hours: Postoperative in PACU

  • Emergence delirium severity

    Within 3 hours: Postoperative in PACU

  • Post-operative behaviour

    Within 2 weeks after surgery

  • Burst Suppression Incidence

    6 hours: within the intraoperative period

  • Burst Suppression Duration

    6 hours: within the intraoperative period

  • +2 more secondary outcomes

Other Outcomes (8)

  • Mean peak alpha frequency

    During maintenance of anaesthesia (up to 4 hours)

  • Mean peak alpha power

    During maintenance of anaesthesia (up to 4 hours)

  • Mean peak slow oscillation frequency

    During maintenance of anaesthesia (up to 4 hours)

  • +5 more other outcomes

Study Arms (2)

EEG-Guided Anaesthesia

EXPERIMENTAL

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 placementDevice: Sedline EEG monitoring

Routine Care

ACTIVE COMPARATOR

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

Interventions

Sedline EEG sensor placementDEVICE

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

EEG-Guided AnaesthesiaRoutine Care
Sedline EEG monitoringDEVICE

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

EEG-Guided Anaesthesia

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The subject and the outcome assessor analysing the EEG subsequently will be blinded to group allocation.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomised Controlled Trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2019

First Posted

September 25, 2019

Study Start

September 26, 2019

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

February 24, 2022

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)