Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients (Maternal voice)

October 29, 2017 updated by: Eugene Kim, Daegu Catholic University Medical Center

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

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

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group M
At the end of surgery, patients were stimulated to wake up by recorded mother's voice, which was recorded before the operation.

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.

Active Comparator: Group S
At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation.

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. "

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
initial PAED score
Time Frame: During 1 minutes after PACU admission
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLACC score on initial, 10, 20, and 30 min
Time Frame: During 60 minutes after PACU admission
Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
During 60 minutes after PACU admission
Extubation time
Time Frame: During 1 hour after operation
time from discontinuation of anesthetics to extubation
During 1 hour after operation
BIS over 60
Time Frame: During 1 hour after operation
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
Incidence of emergence delirium (ED)
Time Frame: During 60 minutes after PACU admission
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
PAED score on 10, 20, and 30 min
Time Frame: During 60 minutes after PACU admission
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
Watcha scale on initial, 10, 20, and 30 min
Time Frame: During 60 minutes after PACU admission

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
During 60 minutes after PACU admission
BIS over 70 and 80 time
Time Frame: During 1 hour after operation
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
mean blood pressure
Time Frame: During 1 hour after operation
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
Heart rate
Time Frame: During 1 hour after operation
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
Eye opening or purposeful movement time
Time Frame: During 1 hour after operation
defined as the interval from the cessation of anesthetics to eye opening or purposeful movement of patients
During 1 hour after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 21, 2017

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 29, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DCUMC_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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