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

D

Daegu Catholic University Medical Center

Status

Completed

Conditions

Anesthesia, General

Treatments

Procedure: recorded stranger's voice
Procedure: recorded maternal voice

Study type

Interventional

Funder types

Other

Identifiers

NCT02955680
DCUMC_2

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

2 to 8 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

66 participants in 2 patient groups

Group M
Experimental group
Description:
At the end of surgery, patients were stimulated to wake up by recorded mother's voice, which was recorded before the operation.
Treatment:
Procedure: recorded maternal voice
Group S
Active Comparator group
Description:
At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation.
Treatment:
Procedure: recorded stranger's voice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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