Anesthesia, General
Conditions
Keywords
emergence agitation, emergence time, pediatric
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
DOUBLE (Subject, 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 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence time | During 1 hour after operation | time from discontinuation of anesthetics to extubation |
| Incidence of emergence delirium (ED) | During 30 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peak Watcha scale | During 30 minutes after PACU admission | The Watcha scale is a four-point as followings. 1. calm 2. crying, but can be consoled 3. Crying, cannot be consoled 4. Agitated and thrashing around |
| 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. |
| eye opening or purposeful movement time | During 1 hour after operation | time from discontinuation of anesthetics to spontaneous eye opening |
| peak PAED scale | During 30 minutes after PACU admission | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| peak FLACC score | During 30 minutes after PACU admission | Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission. |
| The amount of analgesic/anesthetic consumption at PACU/ward | During 1 hour at PACU | The amount of analgesics/anesthetic consumption was checked during hospital admission. At PACU, a total PAED score of \>12 or a FLACC scale \>4, intravenous fentanyl 0.5 mcg/kg was administered as rescue medication and repeated after 10 min if the agitation does not subside. |
Countries
South Korea
Outcome results
None listed