Perioperative EEG-Monitoring and Emergence Delirium in Children

Study Overview
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Brief Summary
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Emergence delirium is a significant problem, particularly in children. However the incidence, preventative strategies, and management of emergence delirium remain unclear. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of emergence delirium in children under 16 years scheduled for elective surgery using electroencephalogram. The Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004) is used to screen for the occurrence of emergence delirium in the post anesthesia care unit.

Official Title
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Perioperative EEG-Monitoring and Emergence Delirium in Children: a Prospective Observational Study

Conditions
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Delirium

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female children aged under 16 years planned elective surgery informed consent by parents or legal guardians Exclusion Criteria: history of neurological or psychiatric disease delayed development inability of the parents or legal guardians to speak or read Chinese participation in another prospective interventional clinical study during this study

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Delirium is determined by PAED score<br> | |
| No delirium is determined by PAED score<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of emergence delirium | The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004).The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity. A peak PAED value ≥ 10 is considered emergence delirium. | Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative power of each brain waves | Electroencephalogram data were acquired using a 32-channel electroencephalogram recording system (Brain Products, Germany). A 5 min, baseline, eyes-closed recording was conducted at the preoperative holding room when the child was at rest. Recording of electroencephalogram was commenced before the start of anesthetic induction and was stopped before discharge of the child from the Post-Anesthesia Care Unit. We defied delta (1 to 3 Hz), theta (4 to 7 Hz), alpha (8 to 12 Hz), and beta (13 to 40 Hz) frequency bands. And then, the relative power of each frequency bands to the total power of the sum is calculated. | from stay at the preoperative holding room to discharge of the child from the Post-Anesthesia Care Unit, , an average of 3 hours | 
| Preoperative anxiety of children | Preoperative anxiety is evaluated using the preoperative modified Yale Preoperative Anxiety Scale (m-YPAS) score (Kain et al. 1997). The modified Yale Preoperative Anxiety Scale (m-YPAS) consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parent). Children's behavior is rated from 1 to 4 or 1 to 6 (depending on the item), with higher numbers indicating the highest severity within that item. Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the vocalizations item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100. This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety. | baseline (At the preoperative holding room) | 
| Compliance of the children during induction | Measured by Induction compliance checklist (Kain et al. 1998). | Procedure (At the beginning of the Induction) | 
| Blood pressure | Systolic and diastolic blood pressures are assessed. | During the operation, an average of 1 hour | 
| Heart rate |  | During the operation, an average of 1 hour | 
| Body temperature |  | During the operation, an average of 1 hour | 
| Duration of anesthesia |  | During the anesthesia, an average of 1 hour | 
| Type of surgery |  | During the operation | 
| Duration of surgery |  | During the operation, an average of 1 hour | 
| Number of Participants with adverse events | Adverse events such as vomiting, cough, breath holding, laryngospasm, and oxygen desaturation are recorded | Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, , an average of 1 hour | 
| The level of consciousness | The level of consciousness is measured by Richmond Agitation Sedation Scale score (Kerson et al. 2016). The Richmond Agitation and Sedation Scale (RASS) is a 10-point scale, with four levels of anxiety or agitation, one level denoting a calm and alert state, and 5 levels of sedation. | Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour | 
| Postoperative pain: FLACC- Scale | Postoperative pain is measured by the FLACC- Scale (Merkel et al. 1997). The Face, Legs, Activity, Cry, Consolability (FLACC ) scale is a measurement used to assess pain for children or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour | 
| Severity of emergence Delirium | The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004).The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity. A peak PAED value ≥ 10 is considered emergence delirium. | Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour | 
| Duration of emergence Delirium | The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004).The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity. A peak PAED value ≥ 10 is considered emergence delirium. | Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour | 
| Post-Anesthesia Care Unit (PACU) stay time | When patients become calm and meet a modified Aldrete score (Aldrete et al. 1995) ≥ 9, they are discharged and the duration of the PACU stay is recorded as the PACU stay time. | During the stay in the Post-Anesthesia Care Unit, an average of 1 hour | 
| Incidence of behavioral problem | The behavioral problem is measured by a modified Version of the Posthospital Behavior Questionnaire (PHBQ) (Stargatt et al. 2006) | Up to 30 postoperative days | 
| Number of Participants with postoperative organ complications |  | Participants will be followed for the duration of hospital stay, an average of 5 days. | 
| Hospital length of stay |  | Participants will be followed for the duration of hospital stay, an average of 5 days. |