Effect of a mother’s recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial
Song et al. Trials
Effect of a mother's recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial
Seok Young Song 0
Sang Gyu Kwak 1
Eugene Kim 0
0 Department of Anesthesiology and Pain Medicine, Daegu Catholic University Medical Center, School of Medicine, Daegu Catholic University , Daegu , Republic of Korea
1 Department of Medical Statistics, Daegu Catholic University Medical Center, School of Medicine, Daegu Catholic University , Daegu , Republic of Korea
Background: Emergence delirium is a behavioral disturbance after general anesthesia in children and may distress both the patients and the primary caregivers, such as parents and medical staff, looking after the patients. Various medical and emotional interventions have been investigated to reduce emergence delirium; however, none are completely effective. This trial intends to assess whether the mother's recorded voice can reduce this adverse post-anesthesia event and facilitate arousal from general anesthesia. Methods/design: This is a prospective, double-blind, single-center, parallel-arm, superiority, randomized controlled trial to be conducted in participants aged 2-8 years who are undergoing elective surgery requiring general anesthesia. Participants will be randomly assigned to one of two groups: those who are stimulated to wake up by listening to their mother's recorded voice (maternal group, n = 33) or a stranger's voice (stranger group, n = 33) during anesthetic emergence. The primary outcome is the initial emergence delirium score in the post-anesthesia care unit (PACU). The secondary outcomes are hemodynamic parameters, including heart rate and mean blood pressure, the duration of time between the cessation of anesthetics and a BIS level of 60, 70 and 80, eye-opening or purposeful movement time, extubation time, total consumption of analgesics, PACU stay time, emergence delirium and pain scores during the PACU stay. Discussion: This is the first randomized controlled trial to investigate the effect of a mother's recorded voice during emergence on the pediatric emergence profile after general anesthesia. It may provide prophylactic treatment options to decrease emergence delirium and enhance arousal from general anesthesia. Trial registration: ClicnicalTrials.gov, ID: NCT02955680. Registered on 2 November 2016.
Emergence agitation; Emergence time; Bispectral index (BIS); General anesthesia; Mother's voice
Background
Emergence delirium (ED) is described as a “mental
disturbance during recovery from general anesthesia consisting of
hallucinations, delusions and confusion manifested by
moaning, restlessness, involuntary physical activity, and
thrashing about in bed” [
1
]. It can cause self-injury, dressing
disruptions, surgical dehiscence, and dislodged indwelling
catheters and can lead to parents’ and surgeons’
dissatisfaction with the anesthetic. The incidence of ED in pediatric
patients after general anesthesia is reported to be between
10 and 80% [
2
]. Several factors, such as sevoflurane or
desflurane anesthesia, younger age, pain, anxiety and the
temperament of the child have been suggested to contribute
to ED, but the precise etiology remains uncertain [
2, 3
].
Various studies have tried to reduce emergence delirium after
anesthesia [
4–6
], but none have been completely effective.
Mothers usually spend a large amount of time with
their children. Therefore, mothers can be assumed to
contribute to their children’s emotional status and
neurological development. In a previous study, maternal
voice had special importance and enhanced involuntary
attention [
7
]. Moreover, a mother’s voice elicited
stronger activations in specific cerebral regions than an
unknown voice in another study [
8
]. A recorded
mother’s voice increased the activation of the prefrontal
cortex compared to a stranger’s voice [
9
]. As shown by
these studies, a mother’s voice has been shown to have a
strong impact on both behavioral and neuronal
responses in children.
However, the influence of a familiar voice, especially a
mother’s voice, on a child during anesthetic emergence
has been scarcely explored previously. Therefore, we will
investigate whether maternal voice supports emotional
stability and facilitates emergence during the emergence
period. We hypothesized that children would show
reduced ED and faster emergence when they heard their
mothers’ recorded voices compared to a stranger’s
recorded voice.
Methods
Study design
This prospective, single-center, parallel-arm,
doubleblind, randomized controlled trial was approved by the
Institutional Review Board (IRB) of Daegu Catholic
University Medical Center (CR-16-139-L) and registered at
ClinicalTrials.gov (NCT02955680) before enrollment.
This trial is conducted in a tertiary university hospital
(Daegu Catholic University Medical Center) in South
Korea. We report the protocol of this trial according to
the SPIRIT guidelines a (...truncated)