Skip to main content
OpenTrials
Completed

NCT Number: NCT02955680

Recorded Maternal 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia, General Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

recorded maternal voice

Procedure

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

Procedure

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. "

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

    • calm
    • crying, but can be consoled
    • Crying, cannot be consoled
    • Agitated and thrashing around

  5. 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.

  6. 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

  7. Extubation time

    Time frame: During 1 hour after operation

    time from discontinuation of anesthetics to extubation

  8. 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.

  9. 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.

  10. 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

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

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

Acronym: Maternal voice

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2016
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.