Maternal Voice on Anesthetic Emergence Period

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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Effect of Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients: a Pilot Study

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 an operation under general anesthesia Exclusion Criteria: ASA PS III or IV with developmental delay or neurological diseases associated with symptoms of agitation refusal of consent with developmental delay with allergy or contraindication to use of ketamine (presence of an active upper respiratory tract infection (URI), 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stranger's voice<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>|
| Experimental: maternal voice<br>At the end of surgery, patients were stimulated to wake up by recorded maternal 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence time | time from discontinuation of anesthetics to extubation | 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. | During 30 minutes after PACU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak PAED scale | 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 30 minutes after PACU admission | 
| peak Watcha scale | The Watcha scale is a four-point as followings. calm crying, but can be consoled Crying, cannot be consoled Agitated and thrashing around | During 30 minutes after PACU admission | 
| eye opening or purposeful movement time | time from discontinuation of anesthetics to spontaneous eye opening | During 1 hour after operation | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergence agitation, emergence time, pediatric