Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients

Study Overview
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Brief Summary
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Mother spend a large amount of time with their children. It is assumed that mother contributes to their neurological development not only with visual stimuli, but also with auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response to the self-name being spoken by the mother than by a stranger. Therefore, investigators suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten the emergence from general anesthesia.

Official Title
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Comparison Between Recorded Mother's and Stranger's Voice on the Emergence of General Anesthesia on Pediatric Patients

Conditions
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Anesthesia, General

Intervention / Treatment
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* Procedure: recorded maternal voice
* Procedure: recorded stranger's voice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged between 2 and 8 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive ophthalmology or otorhinolaryngology surgery under general anesthesia Exclusion Criteria: ASA PS III or IV with developmental delay or neurological diseases associated with symptoms of agitation refusal of consent maternal mutism absence of mother with allergy or contraindication to use of ketamine (increased intracranial pressure, open-globe injury, and a psychiatric or seizure disorder)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 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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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group M<br>At the end of surgery, patients were stimulated to wake up by recorded mother's voice, which was recorded before the operation. | Procedure: recorded maternal voice<br>* A voice recording will be performed before the operation. At a preoperative visit or preoperative clinic, informed consent was obtained before the recording. On a calm environment, the mother was asked to speak following sentences.  OO (first name of child), wake up . Let's go home with mommy. OO, wake up . Open your eyes. Take a deep breath.  At the end of surgery, the recorded maternal voice was delivered to the child every 15 seconds until he/she wakes up.<br>|
| Active Comparator: Group S<br>At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation. | Procedure: recorded stranger's voice<br>* A voice recording will be performed before the operation. On a calm environment, a blinded female investigator was asked to speak following sentences.  OO (first name of child), wake up . Let's go home with mommy. OO, wake up . Open your eyes. Take a deep breath. <br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial PAED score | On arrival at post-anesthesia care unit (PACU), patients were checked PAED. 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. | During 1 minutes after PACU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIS over 60 | At the end of operation, investigators stop the anesthetics and carefully watch the bispectral index (BIS) monitor. Simultaneously, investigators check the duration of time from discontinuation of anesthetics until the BIS >60. | During 1 hour after operation | 
| Incidence of emergence delirium (ED) | The incidence of emergence delirium (ED) was defined as pediatric anesthesia emergence delirium (PAED) score of >12 or Watcha scale over 3 at PACU. | During 60 minutes after PACU admission | 
| PAED score on 10, 20, and 30 min | On arrival at post-anesthesia care unit (PACU), patients were checked PAED. 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. | During 60 minutes after PACU admission | 
| Watcha scale on initial, 10, 20, and 30 min | On arrival and 10, 20, and 30 min after PACU admission, patients were checked Watcha scale as following 4-point scale calm crying, but can be consoled Crying, cannot be consoled Agitated and thrashing around | During 60 minutes after PACU admission | 
| BIS over 70 and 80 time | At the end of operation, investigators stop the anesthetics and carefully watch the bispectral index (BIS) monitor. Simultaneously, investigators check the duration of time from discontinuation of anesthetics until the BIS reached 70 and 80 value. | During 1 hour after operation | 
| FLACC score on initial, 10, 20, and 30 min | Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission | During 60 minutes after PACU admission | 
| Extubation time | time from discontinuation of anesthetics to extubation | During 1 hour after operation | 
| mean blood pressure | Mean blood pressure (MBP) is checked at five time points; cessation of anesthetics (baseline), the BIS reached value of 60, time of extubation, PACU arrival, and PACU discharge. | During 1 hour after operation | 
| Heart rate | Heart rate is checked at five time points; cessation of anesthetics (baseline), the BIS reached value of 60, time of extubation, PACU arrival, and PACU discharge. | During 1 hour after operation | 
| Eye opening or purposeful movement time | defined as the interval from the cessation of anesthetics to eye opening or purposeful movement of patients | During 1 hour after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergence delirium, emergence time, bispectral index