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

NCT02955680 | Completed

• 1 other identifier: DCUMC_2
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, General

Keywords

emergence delirium; emergence time; bispectral index

Outcome Measures

Primary Outcomes (1)

• initial PAED score

  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

Secondary Outcomes (10)

• BIS over 60

  During 1 hour after operation

• Incidence of emergence delirium (ED)

  During 60 minutes after PACU admission

• PAED score on 10, 20, and 30 min

  During 60 minutes after PACU admission

• Watcha scale on initial, 10, 20, and 30 min

  During 60 minutes after PACU admission

• BIS over 70 and 80 time

  During 1 hour after operation

Study Arms (2)

Group M

EXPERIMENTAL

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

Group S

ACTIVE COMPARATOR

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

Interventions

recorded maternal voice PROCEDURE

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.

Group M

recorded stranger's voice PROCEDURE

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. "

Group S

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Related Publications (2)

• 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.

  PMID: 30032889 DERIVED

• 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.

  PMID: 28915907 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Eugene Kim, MD

  Daegu Catholic University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 21, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

KR (1)