Maternal Voice on Anesthetic Emergence Period (MatherVoice)

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General
• Intervention / Treatment: Procedure: recorded stranger's voice; Procedure: recorded maternal voice

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: stranger's voice; At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation.	Procedure: 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. "
Experimental: maternal voice; At the end of surgery, patients were stimulated to wake up by recorded maternal voice, which was recorded before the operation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence time	time from discontinuation of anesthetics to extubation	During 1 hour after operation
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
eye opening or purposeful movement time	time from discontinuation of anesthetics to spontaneous eye opening	During 1 hour after operation
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak FLACC score	Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission.	During 30 minutes after PACU admission
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

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center
• Investigators: Study Director: Eugene Kim, MD, Daegu Catholic University Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: pediatric; emergence agitation; emergence time
• Other Study ID Numbers: DCUMC_1