Depth of AnaesthesiaEEGPACNCT04103138
EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care
A study testing Sedline EEG sensor placement and Sedline EEG monitoring in people with Depth of Anaesthesia and EEG, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Electroencephalographic recordings (EEG) present an opportunity to monitor changes in human brain electrical activity during changing states of consciousness during general anesthesia. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Depth of Anaesthesia, EEG, Anesthesia Emergence Delirium
- What is being tested?
- Sedline EEG sensor placement and Sedline EEG monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Sep 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
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.
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.
Read the 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.
- Conditions
- Depth of Anaesthesia, EEG, Anesthesia Emergence Delirium
- Being tested
- Sedline EEG sensor placement, Sedline EEG monitoring
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedline EEG sensor placementDevice
Patients will have Sedline EEG sensor placed before or immediately after induction.
Sedline EEG monitoringDevice
Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sedline EEG sensor placement; Device: 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. Receives: Device: Sedline EEG sensor placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
End tidal sevoflurane concentration at induction
Average sevoflurane concentration (MAC) required during induction
Measured: 6 hours: within the intraoperative period
End tidal sevoflurane concentration for maintenance
Average sevoflurane concentration (MAC) required during maintenance
Measured: 6 hours: within the intraoperative period
Secondary outcomes (7)
Emergence delirium incidence
Incidence of emergence delirium as measured by the PAED scale
Measured: Within 3 hours: Postoperative in PACU
Emergence delirium severity
Severity of emergence delirium as measured by the PAED scale
Measured: Within 3 hours: Postoperative in PACU
Post-operative behaviour
Post-operative maladaptive behaviour
Measured: Within 2 weeks after surgery
Burst Suppression Incidence
Incidence of burst suppression
Measured: 6 hours: within the intraoperative period
Burst Suppression Duration
Duration of burst suppression
Measured: 6 hours: within the intraoperative period
Burst suppression probability
Burst suppression probability during maintenance, summarized by the mean over the maintenance period
Measured: During maintenance of anaesthesia (up to 4 hours)
PSI
Patient state index during maintenance of anaesthesia
Measured: 6 hours: within the intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start26 Sep 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depth of AnaesthesiaStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103138
- Sponsor's protocol ID
- CIRB 2019/2235
- Acronym
- EEGPAC
- Status last verified
- Jul 2019
- First submitted
- 25 Aug 2019
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care
- ClinicalTrials.gov ID
- NCT04103138
- Acronym / sponsor ID
- EEGPAC / CIRB 2019/2235
- Conditions
- Depth of Anaesthesia, EEG, Anesthesia Emergence Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| EEG-Guided Anaesthesia | Experimental | Device: Sedline EEG sensor placement, Device: Sedline EEG monitoringPatients 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. |
| Routine Care | Active comparator | Device: Sedline EEG sensor placementPatients 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. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedline EEG sensor placementPatients will have Sedline EEG sensor placed before or immediately after induction. | Device | EEG-Guided Anaesthesia, Routine Care |
| Sedline EEG monitoringAnaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters | Device | EEG-Guided Anaesthesia |
Primary outcome
End tidal sevoflurane concentration at induction
Time frame: 6 hours: within the intraoperative period
Average sevoflurane concentration (MAC) required during induction
End tidal sevoflurane concentration for maintenance
Time frame: 6 hours: within the intraoperative period
Average sevoflurane concentration (MAC) required during maintenance
7 secondary outcomes
Emergence delirium incidence
Time frame: Within 3 hours: Postoperative in PACU
Emergence delirium severity
Time frame: Within 3 hours: Postoperative in PACU
Post-operative behaviour
Time frame: Within 2 weeks after surgery
Burst Suppression Incidence
Time frame: 6 hours: within the intraoperative period
Burst Suppression Duration
Time frame: 6 hours: within the intraoperative period
Burst suppression probability
Time frame: During maintenance of anaesthesia (up to 4 hours)
PSI
Time frame: 6 hours: within the intraoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedline EEG sensor placement and Sedline EEG monitoring in people with Depth of Anaesthesia and EEG, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End tidal sevoflurane concentration at induction (time frame: 6 hours: within the intraoperative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.