Anesthesia, General
Conditions
Keywords
emergence delirium, emergence time, bispectral index
Brief summary
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.
Interventions
PROCEDURErecorded maternal 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.
PROCEDURErecorded stranger's voice
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.
Sponsors
Daegu Catholic University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| initial PAED score | During 1 minutes after PACU admission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of emergence delirium (ED) | During 60 minutes after PACU admission | The incidence of emergence delirium (ED) was defined as pediatric anesthesia emergence delirium (PAED) score of \>12 or Watcha scale over 3 at PACU. |
| PAED score on 10, 20, and 30 min | During 60 minutes after PACU admission | 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. |
| Watcha scale on initial, 10, 20, and 30 min | During 60 minutes after PACU admission | 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 |
| BIS over 70 and 80 time | During 1 hour after operation | 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. |
| BIS over 60 | During 1 hour after operation | 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. |
| Extubation time | During 1 hour after operation | time from discontinuation of anesthetics to extubation |
| mean blood pressure | During 1 hour after operation | 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. |
| Heart rate | During 1 hour after operation | 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. |
| Eye opening or purposeful movement time | During 1 hour after operation | defined as the interval from the cessation of anesthetics to eye opening or purposeful movement of patients |
| FLACC score on initial, 10, 20, and 30 min | During 60 minutes after PACU admission | Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission |
Countries
South Korea
Outcome results
None listed