- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02955680
Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients (Maternal voice)
Comparison Between Recorded Mother's and Stranger's Voice on the Emergence of General Anesthesia on Pediatric Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Daegu, Korea, Republic of, 42472
- Daegu Catholic University Medical Center
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group M
At the end of surgery, patients were stimulated to wake up by recorded mother's voice, which was recorded before the operation.
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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. |
Active Comparator: Group S
At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation.
|
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. " |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During 1 minutes after PACU admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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During 60 minutes after PACU admission
|
Extubation time
Time Frame: During 1 hour after operation
|
time from discontinuation of anesthetics to extubation
|
During 1 hour after operation
|
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.
|
During 1 hour after operation
|
Incidence of emergence delirium (ED)
Time Frame: During 60 minutes after PACU admission
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The incidence of emergence delirium (ED) was defined as pediatric anesthesia emergence delirium (PAED) score of >12 or Watcha scale over 3 at PACU.
|
During 60 minutes after PACU admission
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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.
|
During 60 minutes after PACU admission
|
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
|
During 60 minutes after PACU admission
|
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.
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During 1 hour after operation
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mean blood pressure
Time Frame: During 1 hour after operation
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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.
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During 1 hour after operation
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Heart rate
Time Frame: During 1 hour after operation
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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.
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During 1 hour after operation
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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
|
During 1 hour after operation
|
Collaborators and Investigators
Investigators
- Study Director: Eugene Kim, MD, Daegu Catholic University Medical Center
Publications and helpful links
General Publications
- Byun S, Song S, Kim JH, Ryu T, Jeong MY, Kim E. Mother's recorded voice on emergence can decrease postoperative emergence delirium from general anaesthesia in paediatric patients: a prospective randomised controlled trial. Br J Anaesth. 2018 Aug;121(2):483-489. doi: 10.1016/j.bja.2018.01.042. Epub 2018 Apr 17.
- Song SY, Kwak SG, Kim E. Effect of a mother's recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial. Trials. 2017 Sep 15;18(1):430. doi: 10.1186/s13063-017-2164-4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DCUMC_2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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