Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02955680
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : October 31, 2017
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison Between Recorded Mother's and Stranger's Voice on the Emergence of General Anesthesia on Pediatric Patients
Study Start Date : November 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 21, 2017

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.
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.


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.
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. "





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Incidence of emergence delirium (ED) [ Time Frame: 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.

  3. 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.

  4. 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

    1. calm
    2. crying, but can be consoled
    3. Crying, cannot be consoled
    4. Agitated and thrashing around

  5. 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.

  6. 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

  7. Extubation time [ Time Frame: During 1 hour after operation ]
    time from discontinuation of anesthetics to extubation

  8. mean blood pressure [ Time Frame: 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.

  9. Heart rate [ Time Frame: 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.

  10. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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)

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): NCT02955680


Locations
Layout table for location information
Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of, 42472
Sponsors and Collaborators
Daegu Catholic University Medical Center
Investigators
Layout table for investigator information
Study Director: Eugene Kim, MD Daegu Catholic University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eugene Kim, Assistant professor, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT02955680    
Other Study ID Numbers: DCUMC_2
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Keywords provided by Eugene Kim, Daegu Catholic University Medical Center:
emergence delirium
emergence time
bispectral index