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

Daegu Catholic University Medical Center66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Anesthesia, General

Interventions

recorded maternal voicePROCEDURE

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 voicePROCEDURE

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. "

Eligibility

Sex: ALLMin age: 2 YearsMax age: 8 Years

Medical Language ↔ Plain English

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)

Locations (1)

Daegu Catholic University Medical Center

Daegu, South Korea

Outcomes

Primary Outcomes

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.

Time frame: During 1 minutes after PACU admission

Secondary Outcomes

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.

Time frame: 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 at PACU.

Time frame: During 60 minutes after PACU admission

PAED score on 10, 20, and 30 min

Time frame: During 60 minutes after PACU admission

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 1. calm 2. crying, but can be consoled 3. Crying, cannot be consoled 4. Agitated and thrashing around

Time frame: During 60 minutes after PACU admission

Data from ClinicalTrials.gov

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