Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients

Not Applicable

Completed

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

• Registration Number: NCT02955680
• 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: 2016-11
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Primary Completion: 2017-09
• Study Completion: 2017-09-21
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-29
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group M	recorded maternal voice	At the end of surgery, patients were stimulated to wake up by recorded mother's voice, which was recorded before the operation.
Group S	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
initial PAED score	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 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.
Incidence of emergence delirium (ED)	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.
PAED score on 10, 20, and 30 min	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.
Watcha scale on initial, 10, 20, and 30 min	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
BIS over 70 and 80 time	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.
FLACC score on initial, 10, 20, and 30 min	During 60 minutes after PACU admission	Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
Extubation time	During 1 hour after operation	time from discontinuation of anesthetics to extubation
mean blood pressure	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.
Heart rate	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.
Eye opening or purposeful movement time	During 1 hour after operation	defined as the interval from the cessation of anesthetics to eye opening or purposeful movement of patients

Trial Locations

Locations (1)

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