Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

Study Overview
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Brief Summary
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Emergence agitation (EA) is one of the unpleasant symptoms after general anesthesia. The patient can be irritable, uncooperate, cry, moan and combative behaviors. Sometimes the patient may need to be thrashed to prevent physical harm. The mechanism of EA is still unknown. EA is usually self limiting within 45 to 60 minutes after wake up from anesthesia. The incidence of EA is much higher in pediatric group when compared with adult. In some centre the incidence of EA can be up to 67 % depends on anesthesia technique, race, and child's temperament. Kain et al, reported that the patient who had marked EA tended to have post operative maladaptive behaviors. These maladaptive behaviors such as insomnia, eating disturbance, aggressive behavior and even developmental regression can be happen until one year after anesthesia. From the previous study, reported that fast emergence was associated with a high incidence of agitation. This prospective observation study is conducted to determine that emergence time has any effect on EA or not. The authors use process electroencephalogram (entropy) to monitor emergence time which defined as the time which state entropy level over sixty to eighty. Meanwhile, we will evaluate the emergence time by the conventional method which used the time from ceasing anesthesia to the time of eye opening by normal voice stimuli. The primary outcome of this study is the correlation between emergence time (both from Process EEG and clinical presentation) and incidence of emergence agitation. Two secondary outcomes will be measured. Firstly, the correlation between emergence time and postoperative behavioral changes. Secondly, the relationship between entropy monitoring and clinical symptoms.

Official Title
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Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

Conditions
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Emergence Agitation, Post Operative Behavioral Changes

Intervention / Treatment
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* Diagnostic Test: Emergence agitation scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patient aged between 3-12 years, ASA physical status I-II who is scheduled for inpatient elective surgery Exclusion Criteria: emergency surgery, neurosurgery, antiepileptic medication taken and having ICU admission planning.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 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 |
| --- | --- |
| deep anesthetic state<br>technique of Anesthesia at the time of airway device removal | Diagnostic Test: Emergence agitation scale<br>* Emergence agitation scale: PAED scale > 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ<br>* Other names: Post operative behavioral changes;|
| awake<br>technique of Anesthesia at the time of airway device removal | Diagnostic Test: Emergence agitation scale<br>* Emergence agitation scale: PAED scale > 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ<br>* Other names: Post operative behavioral changes;|
| emergence time (clinical): min<br>The duration from the time of anesthestic medications stop and the time that patient spontaneously open their eyes | Diagnostic Test: Emergence agitation scale<br>* Emergence agitation scale: PAED scale > 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ<br>* Other names: Post operative behavioral changes;|
| Emergence time (entropy): min<br>time from Entropy value above 60 to 90 | Diagnostic Test: Emergence agitation scale<br>* Emergence agitation scale: PAED scale > 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ<br>* Other names: Post operative behavioral changes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergence agitation | Pediatric Anesthesia Emergence delirium scale (PAED) PAED > 10 defined as EA positive | evaluate patient within the first 5 minutes after patient arrive PACU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative behavioral changes | PHBQ (post hospitalization behavioral questionnaires) | up to 7 days postoperative period |