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

NCT ID: NCT02955680

Last Updated: 2017-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-09-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Group M

At the end of surgery, patients were stimulated to wake up by recorded mother's voice, which was recorded before the operation.

Group Type: EXPERIMENTAL

recorded maternal voice

Intervention Type: 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 S

At the end of surgery, patients were stimulated to wake up by recorded stranger's voice, which was recorded before the operation.

Group Type: ACTIVE_COMPARATOR

recorded stranger's voice

Intervention Type: 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. "

Interventions

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.

Intervention Type: 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. "

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daegu Catholic University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eugene Kim

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eugene Kim, MD

Role: STUDY_DIRECTOR

Daegu Catholic University Medical Center

Locations

Daegu Catholic University Medical Center

Daegu, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30032889 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28915907 (View on PubMed)

Other Identifiers

DCUMC_2

Identifier Type: -

Identifier Source: org_study_id