Maternal Voice on Anesthetic Emergence Period

Not Applicable

Completed

• Conditions: Anesthesia, General
• Interventions: Procedure: recorded maternal voice; Procedure: recorded stranger's voice

• Registration Number: NCT02860377
• Lead Sponsor: Daegu Catholic University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Primary Completion: 2017-08
• Study Completion: 2017-09
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
maternal voice	recorded maternal voice	At the end of surgery, patients were stimulated to wake up by recorded maternal voice, which was recorded before the operation.
stranger's voice	recorded stranger's voice	At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation.

Primary Outcome Measures

Name	Time	Method
Emergence time	During 1 hour after operation	time from discontinuation of anesthetics to extubation
Incidence of emergence delirium (ED)	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 Outcome Measures

Name	Time	Method
BIS over 60	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.
peak Watcha scale	During 30 minutes after PACU admission	The Watcha scale is a four-point as followings.; 1. calm; 2. crying, but can be consoled; 3. Crying, cannot be consoled; 4. Agitated and thrashing around
eye opening or purposeful movement time	During 1 hour after operation	time from discontinuation of anesthetics to spontaneous eye opening
peak PAED scale	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.

Trial Locations

Locations (1)

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of