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Maternal Voice on Anesthetic Emergence Period (MatherVoice)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860377
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Eugene Kim, 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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Procedure: recorded maternal voice Procedure: recorded stranger's voice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients: a Pilot Study
Study Start Date : August 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Active Comparator: 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.
Procedure: recorded stranger's voice

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. "


Experimental: maternal voice
At the end of surgery, patients were stimulated to wake up by recorded maternal voice, which was recorded before the operation.
Procedure: recorded maternal voice

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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.

    1. calm
    2. crying, but can be consoled
    3. Crying, cannot be consoled
    4. 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 Outcome Measures:
  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.



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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860377


Locations
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Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Sponsors and Collaborators
Daegu Catholic University Medical Center
Investigators
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Study Director: Eugene Kim, MD Daegu Catholic University Medical Center
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Responsible Party: Eugene Kim, Assistant professor, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT02860377    
Other Study ID Numbers: DCUMC_1
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Keywords provided by Eugene Kim, Daegu Catholic University Medical Center:
emergence agitation
emergence time
pediatric