Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedline EEG sensor placement | Device | Patients will have Sedline EEG sensor placed before or immediately after induction. |
|
| 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 |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Singapore | 229899 | Singapore |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Randomised Controlled Trial
Not provided
Not provided
The subject and the outcome assessor analysing the EEG subsequently will be blinded to group allocation.
| Sedline EEG monitoring | Device | Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters |
|
| 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 |
| 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) |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |