Clinical trial NCT02955680: Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients
Official title: Comparison Between Recorded Mother's and Stranger's Voice on the Emergence of General Anesthesia on Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Keywords: emergence delirium
emergence time
bispectral index
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: initial PAED score
timeFrame: During 1 minutes after PACU admission
Secondary outcomes:
measure: BIS over 60
timeFrame: During 1 hour after operation
measure: Incidence of emergence delirium (ED)
timeFrame: During 60 minutes after PACU admission
measure: PAED score on 10, 20, and 30 min
timeFrame: During 60 minutes after PACU admission
measure: Watcha scale on initial, 10, 20, and 30 min
timeFrame: During 60 minutes after PACU admission
measure: BIS over 70 and 80 time
timeFrame: During 1 hour after operation
measure: FLACC score on initial, 10, 20, and 30 min
timeFrame: During 60 minutes after PACU admission
measure: Extubation time
timeFrame: During 1 hour after operation
measure: mean blood pressure
timeFrame: During 1 hour after operation
measure: Heart rate
timeFrame: During 1 hour after operation
measure: Eye opening or purposeful movement time
timeFrame: During 1 hour after operation
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Eugene Kim, MD
role: STUDY_DIRECTOR
References:
citation: Byun S, Song S, Kim JH, Ryu T, Jeong MY, Kim E. Mother's recorded voice on emergence can decrease postoperative emergence delirium from general anaesthesia in paediatric patients: a prospective randomised controlled trial. Br J Anaesth. 2018 Aug;121(2):483-489. doi: 10.1016/j.bja.2018.01.042. Epub 2018 Apr 17.
citation: Song SY, Kwak SG, Kim E. Effect of a mother's recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial. Trials. 2017 Sep 15;18(1):430. doi: 10.1186/s13063-017-2164-4.