Maternal Voice on Anesthetic Emergence Period

Anesthesia, General Clinical Trial

— MatherVoice  

Official title:

Effect of Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860377
• Other study ID #: DCUMC_1
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2020
• 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: 10
• Est. completion date: September 2017
• Est. primary completion date: August 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 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)

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
Other	peak FLACC score	Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission.	During 30 minutes after PACU admission
Other	The amount of analgesic/anesthetic consumption at PACU/ward	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.	During 1 hour at PACU
Primary	Emergence time	time from discontinuation of anesthetics to extubation	During 1 hour after operation
Primary	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.	During 30 minutes after PACU admission
Secondary	peak PAED scale	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 30 minutes after PACU admission
Secondary	peak Watcha scale	The Watcha scale is a four-point as followings.; calm; crying, but can be consoled; Crying, cannot be consoled; Agitated and thrashing around	During 30 minutes after PACU admission
Secondary	eye opening or purposeful movement time	time from discontinuation of anesthetics to spontaneous eye opening	During 1 hour after operation
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