Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients

Anesthesia, General Clinical Trial

— Maternal voice  

Official title:

Comparison Between Recorded Mother's and Stranger's Voice on the Emergence of General Anesthesia on Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955680
• Other study ID #: DCUMC_2
• Status: Completed
• Phase: N/A
• First received: November 2, 2016
• Last updated: October 29, 2017
• Start date: November 2016
• Est. completion date: September 21, 2017

Study information

• Verified date: October 2017
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 21, 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Procedure:
• recorded 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.
• recorded 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. "

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During 1 minutes after PACU admission
Secondary	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.	During 1 hour after operation
Secondary	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.	During 60 minutes after PACU admission
Secondary	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.	During 60 minutes after PACU admission
Secondary	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; calm; crying, but can be consoled; Crying, cannot be consoled; Agitated and thrashing around	During 60 minutes after PACU admission
Secondary	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.	During 1 hour after operation
Secondary	FLACC score on initial, 10, 20, and 30 min	Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission	During 60 minutes after PACU admission
Secondary	Extubation time	time from discontinuation of anesthetics to extubation	During 1 hour after operation
Secondary	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.	During 1 hour after operation
Secondary	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.	During 1 hour after operation
Secondary	Eye opening or purposeful movement time	defined as the interval from the cessation of anesthetics to eye opening or purposeful movement of patients	During 1 hour after operation