Emergence Delirium
Conditions
Brief summary
The hypothesis of this study is that providing continuous binaural beats with a phase difference in alpha frequency during anesthesia can reduce the incidence of emergence agitation in pediatric patients. To test this hypothesis, the occurrence of emergence agitation will be compared between the group that received binaural beats and the group that did not receive binaural beats.
Interventions
OTHERBinaural beats
The binaural beat audio file consists of pure tones with a frequency of 432 Hz in the left ear and 420 Hz in the right ear. It is played through headphones starting 30 minutes before the end of the surgery.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
No
Inclusion criteria
* Children under the age of 7 receiving a strabismus surgery under general anesthesia. * American Society of Anesthesiologists Physical status classification 1-2.
Exclusion criteria
* Pediatric patients with hearing impairment or those who are currently using a hearing aid * Pediatric patients with neurological disorders * Pediatric patients with respiratory disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of emergence delirium in postanesthetic care unit (PACU) | within 1hr after the end of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Paediatric Assessment of Emergence Delirium (PAED) score | within 1hr after the end of surgery (every 10 minutes, the score will be checked) | — |
| Pain score (The Face, Legs, Activity, Cry and Consolability score) | within 1hr after the end of surgery | — |
| EEG analysis during emergence period | Time from discontinuation of sevoflurane to entering to PACU (within 1hr after the end of surgery) | alpha, beta, gamma, delta, slow wave power and their ratio |
Countries
South Korea
Contacts
Primary ContactJi-Hyun Lee, MD
Outcome results
None listed