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Completed

NCT Number: NCT02860377

Maternal Voice on Anesthetic Emergence Period

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.

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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, 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 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)

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. Emergence time

    Time frame: During 1 hour after operation

    time from discontinuation of anesthetics to extubation

  2. Incidence of emergence delirium (ED)

    Time frame: During 30 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.

Secondary outcomes

  1. peak PAED scale

    Time frame: During 30 minutes after PACU admission

    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.

  2. peak Watcha scale

    Time frame: During 30 minutes after PACU admission

    The Watcha scale is a four-point as followings.

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

  3. eye opening or purposeful movement time

    Time frame: During 1 hour after operation

    time from discontinuation of anesthetics to spontaneous eye opening

  4. 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.

Other outcomes

  1. peak FLACC score

    Time frame: During 30 minutes after PACU admission

    Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission.

  2. The amount of analgesic/anesthetic consumption at PACU/ward

    Time frame: During 1 hour at PACU

    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.

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

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

Acronym: MatherVoice

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Jan 29, 2020

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.

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