An interventional study of recorded maternal voice and recorded stranger's voice in Anesthesia, General, sponsored by Daegu Catholic University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2017-10-31.
Sponsored by Daegu Catholic University Medical Center · Not applicable, Interventional, and Supportive care
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.
Daegu Catholic University Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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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
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
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.
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. "
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.
Time frame: During 1 minutes after PACU admission
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.
Time frame: 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.
Time frame: 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.
Time frame: 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 1. calm 2. crying, but can be consoled 3. Crying, cannot be consoled 4. Agitated and thrashing around
Time frame: 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.
Time frame: 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
Time frame: During 60 minutes after PACU admission
Extubation time
time from discontinuation of anesthetics to extubation
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: During 1 hour after operation
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Daegu Catholic University Medical Center