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Effect of a mother's recorded voice on emergence from general anesthesia in pediatric patients: Study protocol for a randomized controlled trial

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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.
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S T U D Y P R O T O C O L Open Access
Effect of a mothers recorded voice on
emergence from general anesthesia in
pediatric patients: study protocol for a
randomized controlled trial
Seok Young Song
1
, Sang Gyu Kwak
2
and Eugene Kim
1*
Abstract
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 mothers 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 28 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
mothers recorded voice (maternal group, n=33) or a strangersvoice(strangergroup,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 mothers 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.
Keywords: Emergence agitation, Emergence time, Bispectral index (BIS), General anesthesia, Mothersvoice
Background
Emergence delirium (ED) is described as a mental disturb-
ance 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 parentsand surgeonsdissatisfac-
tion 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]. Vari-
ous studies have tried to reduce emergence delirium after
anesthesia [46], 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 childrens emotional status and
* Correspondence: tomomie@cu.ac.kr
1
Department of Anesthesiology and Pain Medicine, Daegu Catholic
University Medical Center, School of Medicine, Daegu Catholic University,
Daegu, Republic of Korea
Full list of author information is available at the end of the article
© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Song et al. Trials (2017) 18:430
DOI 10.1186/s13063-017-2164-4
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
neurological development. In a previous study, maternal
voice had special importance and enhanced involuntary
attention [7]. Moreover, a mothers voice elicited
stronger activations in specific cerebral regions than an
unknown voice in another study [8]. A recorded
mothers voice increased the activation of the prefrontal
cortex compared to a strangers voice [9]. As shown by
these studies, a mothers voice has been shown to have a
strong impact on both behavioral and neuronal re-
sponses in children.
However, the influence of a familiar voice, especially a
mothers 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
mothersrecorded voices compared to a strangers re-
corded voice.
Methods
Study design
This prospective, single-center, parallel-arm, double-
blind, randomized controlled trial was approved by the
Institutional Review Board (IRB) of Daegu Catholic Uni-
versity 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 and the SPIRIT flow chart (Fig. 1
and Additional file 1, respectively). This protocol also
follows the CONSORT Statement.
Participants
Pediatric patients aged 28 years with an American
Society of Anesthesiologists physical status (ASA PS) of
1 or 2 who are scheduled to undergo ophthalmology or
otorhinolaryngology surgery requiring general anesthesia
will be enrolled. Potential participants who meet the
inclusion criteria will be recruited at outpatient clinics
or during preoperative visits before surgery. The exclu-
sion criteria are described as follows:
ASA PS 3 or 4
Presence of developmental delays or neurological
diseases
Deafness or hearing impairments
Enrollment Allocation Post-allocation
TIMEPOINT Pre-allocation preoperative T1T2T3T4T5T6T7T8
ENROLLMENT:
Eligibility screen X
Informed consent X
Voice recording X
Allocation X
INTERVENTIONS:
[recorded mother’s voice]
[recorded stranger’s voice ]
ASSESSMENTS:
Baseline variables XX
mYPAS X
BIS
ETsevo %X
Hemodynamic parameters*
Extubation time, eye opening time
BIS >60, 70, and 80 time
PAED and Watcha score
FLACC score
Postoperative analgesics
Primary caregiver satisfaction X
Fig. 1 The SPIRIT flow diagram: the schedule of enrollment, interventions and assessments. *including mean blood pressure and heart rate, T
1
at
preoperative waiting area, T
2
cessation of anesthetics, T
3
extubation, T
4
PACU arrival, T
5
10 min after post-anesthesia care unit (PACU) arrival, T
6
20 min after PACU arrival, T
7
30 min after PACU arrival, T
8
PACU discharge, mYPAS modified Yale Preoperative Anxiety Scale, BIS Bispectral Index,
ET
sevo
end-tidal sevoflurane concentration, PAED Pediatric Assessment of Emergence Delirium, FLACC face, legs, activity, cry and consolability
Song et al. Trials (2017) 18:430 Page 2 of 6
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
History of allergies or contraindications to the use of
ketamine (increased intracranial pressure, open-globe
injury,orapsychiatricorseizuredisorder)
Maternal mutism
Absence of the mother
Ethics, consent and permissions
We will obtain written informed consents from all of the
legal guardians of the participants via a single investiga-
tor (SYS) prior to any study-related procedures.
Randomization and blinding
After recruitment, the participants will be randomized
to the maternal group or the stranger group with a 1:1
ratio (Fig. 2) using a computerized online tool (www.
Randomization.com). A random sequence will be
managed and kept within sealed, opaque envelopes by
an assistant who is not involved in this study. When a
patient is enrolled in the study, an anesthesia nurse will
open a sealed envelope and prepare the mothersora
strangers recorded voice file using a voice recorder
according to the group allocation. The voice recorder
will be delivered to the operating room after the patient
arrives and will be connected to noise-cancelling head-
phones before surgical draping.
Allocations will be concealed to all investigators and
participants except the anesthesia nurse who delivers the
voice recorder to the investigator. If serious adverse events
that threaten the safety of patients occur (such as death or
irreversible injury), we will stop the intervention immedi-
ately, break the blinding, and contact the IRB.
Withdrawal, dropout, and discontinuation
Participants are free to withdraw at any time during the
trial at their own or their legal representatives request.
If the continuation of the trial may threaten the partici-
pants health, a participant can be withdrawn based on
the investigatorsjudgment. Reasons for withdrawal will
be recorded in case report form. All data will be
analyzed according to the intention-to-treat principle.
Confidentiality
Personal information including names, social security
numbers or chart numbers will not be collected. Only
the study code will be collected and managed separately.
The collected data will remain confidential until the in-
vestigators analyze the data. The final dataset will be
managed by the chief investigator (EK). After the com-
pletion of the study, the collected data will be encrypted
and stored for 3 years and then discarded.
Intervention
At the preoperative waiting room, patients are premedi-
cated with atropine (0.02 mg/kg) and ketamine (1 mg/kg)
administered intravenously in the parental presence. After
a patient enters the operating room, standard monitoring
Fig. 2 CONSORT flow chart
Song et al. Trials (2017) 18:430 Page 3 of 6
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(electrocardiography, noninvasive arterial blood pressure,
and pulse oximetry) and the Bispectral Index (BIS; VIS-
TATM monitoring system; Aspect Medical Systems Inc.,
Norwood, MA, USA) will be applied. Anesthesia will be
induced using fentanyl (1 mcg/kg) and 56% of
sevoflurane via a scented facial mask. Rocuronium 0.6
0.8 mg/kg will be given to facilitate intubation. Anesthesia
will be maintained with 1.52.0 MAC of sevoflurane
and 50% oxygen, with a BIS target range of 4060.
At the end of the operation, pyridostigmine and
glycopyrrolate will be administered to antagonize
neuromuscular blockade. All patients will be given
prophylactic antiemetics with dexamethasone 0.1 mg/kg
and ondansetron 0.1 mg/kg.
According to the pre-assigned allocation, the patients
will be stimulated to wake up by a repeated recording of
the mothers voice (maternal group) or a strangers voice
(stranger group) at the end of the operation. The voice
recording will be performed before the operation. In a
calm environment, the mother or a woman who does
not know the child is asked to speak the following
sentences in her usual tone of voice:
OO (first name of child), wake up. Lets go home
with mommy. OO, wake up. Open your eyes. Take a
deep breath.
Only light patting on the shoulder and the recorded
voice will be allowed to stimulate the patients. The re-
corded voice will be delivered to the patient repeatedly
via noise cancelling headphones until extubation. An
investigator who is blinded to the assigned intervention
(EK) will check the BIS value and the end-tidal sevoflur-
ane concentration (ET
sevo
%) at the end of surgery, the
extubation time, the eye opening or purposeful move-
ment time and the time to BIS values of > 60, 70, and 80
during the emergence period. The BIS value will be
included if the electromyography score is < 50% and the
Signal Quality Index is > 75%. After gentle suctioning of
oral secretions from the oropharynx, extubation will be
carefully performed when the participants are able to
achieve spontaneous breathing and obey verbal
commands. Voice stimulation via headphones will be
maintained until the patients arrive at the post-
anesthesia care unit (PACU).
Measurements
The primary outcome measurement is the initial PAED
score in the PACU. The secondary outcomes are
hemodynamic parameters (heart rate, mean blood
pressure), the duration of time from the cessation of an-
esthetics to a BIS score of 60/70 and 80 (BIS > 60/70/
80 time), the eye-opening or purposeful movement time,
the extubation time, the total consumption of analgesics,
PACU stay time, and PAED, Watcha, and FLACC scores
in the PACU.
The Modified Yale Preoperative Anxiety Scale (m-
YPAS) will be used when the patients arrive at the
preoperative waiting room with their parents before pre-
medication [10, 11]. At the end of surgery, all anesthetics
will be stopped immediately and the BIS value and the
end-tidal sevoflurane concentration (ET
sevo
%) are
recorded. Hemodynamic parameters, including heart
rate (HR) and mean blood pressure (MBP), will be
checked at five time points; at the time of the cessation
of anesthetics (baseline, t
0
), time to reach a BIS value of
60 (t
1
), time of extubation (t
2
), time of PACU arrival (t
3
),
and time of PACU discharge (t
4
). BIS > 60, 70, and 80
times, defined as the time intervals from the cessation of
anesthetics until the BIS reached values of 60, 70, and
80, respectively, will be measured. Eye-opening or
purposeful movement time is defined as the interval
from the cessation of anesthetics to-eye opening or
purposeful movement of the patient. Extubation time,
defined as the interval from the cessation of anesthetics
until extubation, will also be measured.
Upon arrival to the PACU, a blinded investigator will
measure emergence delirium and pain scores at every
10 min for the first 30 min. Emergence delirium will be
measured by two methods, the Pediatric Assessment of
Emergence Delirium (PAED) and the Watcha scales.
The PAED scale has five categories (eye contact, actions,
awareness, restlessness, and consolability) scored from 0
to 4 and summed to obtain a total score with a range of
020 [12]. The degree of emergence delirium increased
directly with the total scores. The Watcha scale is a
four-point scale as follows [13]: 1, calm; 2, crying but
can be consoled; 3, crying and cannot be consoled; 4, ag-
itated and thrashing around. A total PAED score > 12 or
a Watcha score > 2 at any time is considered post-
anesthetic ED. Pain will be measured by Face, Legs, Ac-
tivity, Cry and Consolability (FLACC) scores ranging
from 0 to 15 [14]. In patients with a total PAED score >
12, a Watcha score > 2 or a FLACC score > 4 in the
PACU, fentanyl 0.5 mcg/kg will be administered as a res-
cue medication and repeated if the agitation does not
subside. Adverse events, such as postoperative nausea
and vomiting, excessive secretions, laryngospasm, or
desaturation and the total consumption of analgesics,
will also be measured. The patients will be discharged
when they are calm and meet a modified Aldrete
score 9 [15], and the duration of the PACU stay will
be recorded as the PACU stay time. The subjective
satisfaction of the primary care giver such as a parent
or the PACU nurse will be measured just before
PACU discharge on a five-point scale as follows: 1,
very disappointed; 2, disappointed; 3, so-so; 4, satis-
factory; 5, very pleased.
Song et al. Trials (2017) 18:430 Page 4 of 6
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Sample size
The primary outcome is the initial PAED score. In our
pilot study, the mean difference of the PAED score
between the stranger group and the maternal group was
1.6 with a standard deviation (SD) of 2.19. To attain an
alpha value of 0.05 and a test power of 0.8, 30 patients
are needed in each group using the following formula
[16]. We plan to enroll a total of 66 patients to allow for
a 10% dropout rate:
n¼2za=2þzβ

2σ2
μcμt
ðÞ
2
To compensate for the possibility of an over-estimated
effect size of the pilot study, we will perform an interim
analysis at 50% enrollment. If the sample size has signifi-
cantly lower power than our expectation, we will recruit
more patients. Otherwise, we will continue the study
according to our initial sample size calculation.
Statistical analysis
An intention-to-treat analysis will be performed and
missing data will be input with the last-observation-
carried-forward method. Continuous variables will be
presented as the mean and the SD or the median and
the interquartile range (IQR) according to the normality
assumption using the Kolmogorov-Smirnov test.
Categorical variables will be presented as numbers of
patients and proportions.
The primary outcome (the initial PAED score) will be
compared with an independent ttest or a Mann-
Whitney Utest. For secondary outcomes, continuous
variables will be compared with an independent ttest or
the Mann-Whitney Utest and categorical variables will
be compared with Pearsons chi-squared test or Fishers
exact test. All tests are two-sided and P<0.05 is considered
statistically significant. A statistician (SGK) who is not
involved in the data collection will conduct all statistical
analyses with SPSS software (version 21.0; SPSS Inc., IBM,
Chicago, IL, USA).
Discussion
The effect of a mothers voice elicited positive physio-
logic and behavioral responses in other clinical territor-
ies [1719], but this has been scarcely reported in
perioperative settings. In a study by Kim and colleagues
[20], a mothers recorded voice reduced preoperative
anxiety and emergence agitation during cardiac
catheterization using ketamine sedation. However, the
quality of mothersvoices was not standardized and the
control group did not receive any voice stimuli. In
contrast, we had the mothers read the same dialogue in
a calm environment in all study populations and
compared the mothersvoices with the strangers voice.
Additionally, we measured the BIS to quantify the
sedation level and the effects of a mothers voice on the
emergence of her child compared with a strangers voice.
Other major differences are the level of anesthesia and
the surgical stimuli. Our study involves investigation
under general anesthesia using both ketamine and
sevoflurane inhalation, but Kims study was conducted
under modest sedation using ketamine only [20]. Sevo-
flurane or desflurane anesthesia is believed to contribute
to a higher frequency of emergence delirium [21].
In this study, patients are premedicated with ketamine
before entry to the operating room. Various agents have
been shown to be beneficial effect on prevention of ED
[36, 2224]. Among the numerous drugs, a new
selective α
2
-agonist, dexmedetomidine has recently been
spotlighted as an effective prophylactic and treatment
agent for ED [2, 6, 22]. Despite the ongoing encourage-
ment from the previous findings, however, there have
been no officially approved indications for its use in the
pediatric population. Meanwhile, ketamine has been
safely used in pediatric anesthesia for over five decades.
It effectively decreased the incidence of emergence
delirium in previous studies [23, 24]. Moreover, it was
equally effective as dexmedetomidine in a study after
strabismus surgery with sevoflurane [25]. Taken all
together, we thought that ketamine would be suitable for
our settings.
To our knowledge, this is the first randomized
controlled trial to investigate the advantage of a mothers
recorded voice during the emergence period on the
pediatric emergence profile after general anesthesia. If
the study is successful, this research will establish a new
prophylactic option to decrease emergence delirium and
enhance the wake up after general anesthesia.
Trial status
Patient recruitment is still ongoing since November 2016.
Additional file
Additional file 1: SPIRIT Checklist. (DOC 123 kb)
Abbreviations
BIS: Bispectral Index; FLACC: Face, Legs, Activity, Cry and Consolability; m-
YPAS: Modified Yale Preoperative Anxiety Scale; PACU: Post-anesthesia care
unit; PAED: Pediatric Assessment of Emergence Delirium
Acknowledgements
The authors are grateful to Sun-Kyung Park and Eon-Suk Um (head nurse and
charge nurse of PACU, respectively) for acquisition of data and managing the
participants for this trial.
Funding
None.
Availability of data and materials
Not applicable.
Song et al. Trials (2017) 18:430 Page 5 of 6
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Authorscontributions
SYS is responsible for the acquisition and interpretation of data and for drafting the
manuscript. SKG is responsible for the design of the study, interpretation of data,
data analysis and revising the manuscript. EK is responsible for the conception and
design of the study, interpretation and analysis of data, and drafting and revising
the manuscript. All authors read and approved the final manuscript.
Ethics approval and consent to participate
As indicated in the section Study design,Institutional Review Board of Daegu
Catholic University Medical Center approved this research protocol (version 1.0,
reference number: CR-16-139-L, validated in October, 2016). This trial is conducted
according to the World Medical Association Declaration of Helsinki. As indicated
in the Methodssection, we will obtain written informed consents from all the
legal guardians or parents of the participants via a single investigator (SYS) prior to
any study-related procedures.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
PublishersNote
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
Author details
1
Department of Anesthesiology and Pain Medicine, Daegu Catholic
University Medical Center, School of Medicine, Daegu Catholic University,
Daegu, Republic of Korea.
2
Department of Medical Statistics, Daegu Catholic
University Medical Center, School of Medicine, Daegu Catholic University,
Daegu, Republic of Korea.
Received: 7 February 2017 Accepted: 29 August 2017
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... The human ear can recognize and analyze analog signals, but the computer cannot analyze them. Because computers flow information in binary form, it is necessary to convert speech signals from analog to digital (11). The basic process is generally divided into two parts: sampling processing and quantization processing. ...
Article
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With the advent of the era of artificial intelligence, speech recognition engine technology has a profound impact on social production, life, education, and other fields. Voice interaction is the most basic and practical type of human-computer interaction. To build an intelligent and automatic physical education teaching mode, this paper combines human-computer interaction based on speech recognition technology with physical education teaching. Students input through voice signals, and the system receives signals, analyzes signals, recognizes signals, and feeds back information to students in multiple forms. For the system to process the external speech signal, this paper uses the Mel cepstral coefficient algorithm to extract the speech information. By comparing the speech recognition rate and antinoise rate of Hidden Markov Model, Probabilistic Statistics Neural Network, and Hybrid Model (Hidden Markov and Rate Statistical Neural Network combination), the speech recognition engine uses the hybrid model, and its speech recognition rate is 98.3%, and the average antinoise rate can reach 85%. By comparing the human-computer interaction physical education teaching method with the traditional teaching method, the human-computer interaction method is superior to the traditional teaching method in the acquisition of physical knowledge, the acquisition of physical skills, the satisfaction of physical education courses and the ability of active learning. It effectively solves the drawbacks of traditional physical education and rationally uses human-computer interaction technology. On the basis of not violating physical education, realize the diversification of physical education, improve the quality of teaching, improve students' individual development and students' autonomous learning ability. Therefore, the combination of human-computer interaction and physical education based on recognition engine technology is the trend of today's physical education development.
... Studies are limited in terms of exploring the effect of family members' voices and the family information given. Although one study found that the mother's voice may reduce the incidence of postoperative delirium in her children [31], the study sample characteristics and delirium assessment were significantly different from those in the studies included in our analysis. ...
Article
Delirium is one of the common manifestations of acute brain dysfunction in critically ill patients. We aimed to evaluate the effect of family intervention on reducing the delirium incidence in patients hospitalized in the intensive care unit (ICU). We searched electronic databases for randomized clinical trials, cohort, and before-and-after studies up to September 2021 using the MeSH terms (“family” OR “family caregiver”) AND (“delirium”). A total of 6 studies including 4199 patients were analyzed. Compared to the control group, the risk of delirium was 24% lower in the family intervention group (OR 0·76 [0·67–0·86], P = 0.20, I² = 31%). Pooled data from two trials showed that family intervention was associated with fewer delirium days (SMD: −1.13, 95% CI: −1.91 to −0.34; P = 0.08; I² = 67%;). However, there were no significant differences between the two groups in the length of ICU stay, mechanical ventilation duration, and mortality (ICU stay days: MD: −0.62 days; 95% CI: −1.49 to 0.24; P = 0.14; I² = 72%; mechanical ventilation days: MD: −0.48 days; 95% CI: −2.10 to 1.13; P = 0.56; I² = 0%; mortality: OR: 0.68, 95% CI: 0.22 to 2.09; P = 0.08; I² = 67%). Current evidence supports the use of family intervention in reducing the delirium risk and delirium days in hospitalized ICU patients. However, its effects on reducing ICU stay length, ventilation duration, and mortality require further study. Future research should consider identifying the specific family intervention strategies and their duration.
Article
Peri-extubation delirium is a clinical syndrome caused by multiple factors, and it is not a simple disease. It occurs within a period of time after extubation when the effect of general anesthesia is reduced. And the incidence is different in disparate populations, and it is more common in elderly patients. Current studies have shown that iatrogenic factors and patients' own factors are the main risk factors for the syndrome. Early identification of risk factors can help clinicians make early diagnosis. The earlier the diagnosis and treatment begin, the more significantly the prognosis of patients can be improved. At present, the treatment of perioperative delirium is based on non-drug therapy, supplemented by drug therapy. This review will introduce in detail the risk factors, population status and prevention measures of delirium during peri-extubation, and look forward to the new research direction in the future.
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Background: Emergence delirium is a behavioural disturbance after general anaesthesia in children that can distress patients, parents, and primary caregivers. We hypothesised that listening to the mother's recorded voice can reduce ED compared with listening to a stranger's recorded voice. Methods: This prospective, double-blind, randomised study was conducted in 2- to 8-yr-old patients who had undergone general anaesthesia. Sixty-six patients were randomly assigned to listen to either the mother's voice (Group M, n=33) or a stranger's voice (Group S, n=33). The primary outcome was the initial paediatric assessment of emergence delirium (PAED) score on arrival at a postanaesthesia care unit (PACU). Other outcomes were the incidence of emergence delirium; Watcha, PAED, and pain scores; PACU stay time; durations between cessation of anaesthetics and bispectral index (BIS) levels of 60, 70, and 80; eye opening time; extubation time; and total consumption of analgesics during the PACU stay. Results: The mother's voice reduced the initial PAED score compared with a stranger's voice [mean (standard deviation), 9.8 (2.5) vs 12.5 (4.1); P=0.002]. The incidence of emergence delirium during the PACU stay was higher in Group S than in Group M [60.6% vs 24.2%, odds ratio (95% confidence interval): 4.88 (1.7-13.9); P=0.006]. The BIS >60 time was shorter in Group M than in Group S (P=0.006). Conclusions: The mother's voice reduced emergence delirium scores and the incidence of emergence delirium in paediatric patients compared with a stranger's voice after general anaesthesia. Clinical trial registration: NCT 02955680.
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Objective: A prospective, double-blind, randomized controlled trial to compare the effect of preoperative midazolam or ketamine on the incidence of emergence agitation (EA) following sevoflurane anaesthesia in children. Methods: Paediatric patients (2-6 years old) undergoing ophthalmic surgery were allocated to receive premedication with either 0.1 mg/kg midazolam or 1 mg/kg ketamine. Incidence of EA and postoperative pain scores were recorded at 10-min intervals in the postanaesthetic care unit (PACU). The use of EA rescue medications (fentanyl or midazolam) was recorded. Results: The incidence of EA was significantly lower in the ketamine group (n = 33) than the midazolam group (n = 34) at 10 and 20 min after transfer to PACU. There was no significant difference in overall incidence of EA. The frequency of midazolam use as rescue medication was significantly lower in the katamine group than in the midazolam group. Conclusion: Premedication with ketamine is more effective than midazolam in preventing EA during the early emergence period after sevoflurane anaesthesia in children.
Article
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Purpose: The modified Yale Preoperative Anxiety Scale (mYPAS) was developed for evaluating the level of preoperative anxiety in children. The purpose of this study was to develop a Korean version of the mYPAS (K-mYPAS) and to establish its validity and reliability based on the Korean preoperative pediatric patients. Methods: K-mYPAS was made through stringent back-translation procedure. Total enrolled 102 patients answered questionnaires of Korean version of State-Trait Anxiety Inventory for Children (K-STAIC), and were videotaped for 2 to 5 minutes before induction of anesthesia. Three observers of experienced psychiatrist, surgeon, and nurse analyzed videotape with K-mYPAS comparing to K-STAIC. The inter- and intraobservers reliability, concurrent and construct validity, sensitivity, specificity, and predictive value were analyzed. Results: The value of Cronbach α for interobservers reliability was 0.939 and intraobserver reliability was statistically significant (P < 0.001). Concurrent and construct validity were also statistically significant (P < 0.001 and P < 0.001, respectively). Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 81.3%, 91.4%, 81.3%, 91.4%, and 88.2%, respectively. Conclusion: The K-mYPAS had good psychometric properties and can be used as a reliable and valid instrument for the assessment of preoperative anxiety in children.
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Due to devastating effects of pain in neonates, it is very important to ease it though safe and feasible methods. This study was to determine the effect of familiar auditory stimuli on the arterial blood sampling (ABS) induced pain in term neonates. This study was done on 30 newborns hospitalized in neonate intensive care unit (NICU) of a hospital in Tehran. Research samples were selected by using convenience sampling and randomly divided into two groups of control and test. In the test group, the recorded mothers' voices were played for the newborns before and after blood sampling procedure. Then, pain measures were recorded 10 minutes before, during and 10 minutes after blood collection based on Neonatal Infant Pain Scale (NIPS); then the pain level changes were reviewed and studied. The findings showed significant differences between the control and test groups that indicating the effect of mother's voice on reducing the pain of neonates during the ABS (p<0.005). Research findings demonstrate that mother's voice reduces ABS induced pain in the term neonates.
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We conducted a randomized trial to test the hypothesis that mother's voice played through a pacifier-activated music player (PAM) during nonnutritive sucking would improve the development of sucking ability and promote more effective oral feeding in preterm infants. Preterm infants between 34 0/7 and 35 6/7 weeks' postmenstrual age, including those with brain injury, who were taking at least half their feedings enterally and less than half orally, were randomly assigned to receive 5 daily 15-minute sessions of either PAM with mother's recorded voice or no PAM, along with routine nonnutritive sucking and maternal care in both groups. Assignment was masked to the clinical team. Ninety-four infants (46 and 48 in the PAM intervention and control groups, respectively) completed the study. The intervention group had significantly increased oral feeding rate (2.0 vs 0.9 mL/min, P < .001), oral volume intake (91.1 vs 48.1 mL/kg/d, P = .001), oral feeds/day (6.5 vs 4.0, P < .001), and faster time-to-full oral feedings (31 vs 38 d, P = .04) compared with controls. Weight gain and cortisol levels during the 5-day protocol were not different between groups. Average hospital stays were 20% shorter in the PAM group, but the difference was not significant (P = .07). A PAM using mother's voice improves oral feeding skills in preterm infants without adverse effects on hormonal stress or growth.
Article
Background: The cause of emergence agitation (EA) in children is unknown. Rapid emergence from inhaled anesthesia has been implicated because EA is more common with sevoflurane than with halothane. A dose-dependent effect of sevoflurane, which increases seizure-like electroencephalogram activity, has also been proposed. Methods: To determine whether depth of anesthesia as measured by bispectral index (BIS) affects EA, 40 ASA physical status I to II children aged 2 to 8 years undergoing ophthalmic surgery were enrolled in a blinded randomized controlled trial of low-normal (40-45, deep) versus high-normal (55-60, light) anesthesia. To distinguish transient irritability from severe EA, the primary outcome was first-stage postanesthesia care unit (PACU I) peak Pediatric Assessment of Emergence Delirium (PAED) score, with secondary outcomes of PAED and Face, Legs, Activity, Cry, and Consolability scores at emergence, postoperative fentanyl dose, emergence time, and discharge time. Subjects received a standard anesthesia protocol with oral midazolam followed by mask induction with sevoflurane 8%, fentanyl 1 to 1.5 μg/kg IV (then as needed), neuromuscular blockade, and endotracheal intubation. Providers titrated expired sevoflurane (in N2O 67%) from 0.5% to 3% to maintain BIS range. PAED, Richmond Agitation Sedation Scale, and Face, Legs, Activity, Cry, and Consolability scores were measured at emergence, at PACU I arrival, and during PACU I stay. Results: There was little difference between the groups in the primary outcome, peak PACU I PAED score (light: 7.7 ± 4.6; deep: 8.6 ± 5.3; mean difference, 0.9; 95% confidence interval, 4.1 to -2.3; effect size, 0.18). Discharge times were similar between groups. Treatment for severe EA was rare. Conclusions: There was no significant effect of BIS-guided deep versus light anesthesia on severe EA.
Article
Background: Administration of dexmedetomidine (DEX) in the pediatric population for its sedative, analgesic, and anxiolytic properties has been widely reported, despite there being no label indication approved by the U.S. Food and Drug Administration for pediatric patients. Infusions of DEX, rather than bolus administration, are recommended to attenuate the hemodynamic response caused by the α2-adrenoreceptor agonist. In this prospective, double-blind, randomized study, we examined the effect of rapid IV bolus injection of DEX on emergence agitation and the hemodynamic response in a large sample of children undergoing tonsillectomy with or without adenoidectomy, with or without myringotomy, and/or tympanostomy tube insertion. Methods: Four hundred patients, aged 4 to 10 years, undergoing tonsillectomy with or without adenoidectomy, with or without myringotomy, and/or tympanostomy tube insertion, were randomized at a 1:1 ratio into 1 of the 2 treatment groups in a double-blinded fashion. After a standardized anesthetic regimen and approximately 5 minutes before the end of surgery, patients in group DEX were administered a rapid IV bolus of 4 μg·mL DEX at a dose of 0.5 μg·kg, whereas patients in group saline received a rapid IV bolus of equivalent volume saline. Baseline measurements of heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, and blood oxygen saturation were collected immediately before study drug administration and every minute thereafter for 5 minutes. In the postanesthesia care unit, vital signs were measured, emergence agitation (EA) was assessed using the Pediatric Anesthesia Emergence Delirium scale, and postoperative opioid use and complications were recorded. Results: The incidence of EA in group DEX was significantly lower than that in group saline, regardless of whether EA was defined as a Pediatric Anesthesia Emergence Delirium score >10 (36% vs 66%, respectively; P < 0.0001; relative risk [95% confidence interval] = 0.527 [0.421-0.660]; number needed to treat = 3.33) or >12 (30% vs 61%, respectively; P < 0.0001; relative risk [95% confidence interval] = 0.560 [0.458-0.684]; number needed to treat = 3.23). Both groups exhibited similar baseline vital signs before study drug injection (all P ≥ 0.602). After injection, group DEX experienced a significant decrease in heart rate for all time points in comparison with group saline (all P < 0.0001). A significant, biphasic blood pressure response was observed in group DEX, specifically, a transient increase in systolic blood pressure at 1 minute after injection (P < 0.0001) and a subsequent decrease below baseline for 3, 4, and 5 minutes (all P < 0.0001). No patients required treatment for bradycardia, hypertension, or hypotension. A significantly smaller percentage of patients in group DEX received postoperative, supplemental opioid medication compared with group saline (48% vs 73%, respectively; P < 0.0001). Group DEX appeared to experience fewer adverse events than group saline as well (9% vs 17%, respectively; P = 0.025). Conclusions: Rapid IV bolus administration of DEX in children improved their recovery profile by reducing the incidence of EA. A statistically significant change in hemodynamics was observed, but no patients required any intervention for hemodynamic changes. Furthermore, DEX reduced the incidence of postoperative opioid administration, and a trend of fewer adverse events was observed in group DEX.
Article
Background: Emergence agitation (EA) is a common behavioral disturbance after sevoflurane anesthesia in children. Propofol 1 mg · kg(-1) bolus at the end of sevoflurane anesthesia has had mixed results in reducing the incidence of EA, whereas propofol infusion throughout anesthesia maintenance seems effective but is more complex to administer. If a simple, short transition to propofol anesthesia was found to be effective in reducing EA, this could enhance the recovery of children following sevoflurane anesthesia. We therefore aimed to determine whether transition to propofol over 3 min at the end of sevoflurane anesthesia reduces the incidence of EA in children. Methods: In this prospective randomized controlled trial, 230 children aged 1-12 years, undergoing magnetic resonance imaging (MRI) scans under sevoflurane anesthesia were randomized to receive either propofol 3 mg · kg(-1) over 3 min (propofol group), or no propofol (control group), at the end of sevoflurane anesthesia. EA was assessed by a blinded assessor using the Pediatric Emergence Anesthesia Delirium (PAED) scale and the Watcha scale until 30 min after emergence. EA on the PAED scale was defined as a PAED score >12. EA on the Watcha scale was defined as a score ≥ 3. Times to emergence, postanesthesia care unit (PACU) discharge, and discharge home were also recorded. Results: Data were analyzed for 218 children. The incidence of EA was lower in the propofol group on both PAED (29% vs 7%; relative risk = 0.25; 95% confidence interval 0.12-0.52; P < 0.001) and Watcha (39% vs 15%; relative risk = 0.37; 95% confidence interval 0.22-0.62; P < 0.001) scales. Duration and severity of EA were also reduced in the propofol group. Preplanned subgroup analyses for midazolam premedication, preexisting cognitive or behavioral disturbance, and age group did not alter our findings. Emergence time and time in PACU were both increased by a mean of 8 min in the propofol group (P < 0.001) with no difference in time to discharge home. Conclusions: Transition to propofol at the end of sevoflurane anesthesia reduces the incidence of EA and improves the quality of emergence. There is a small increase in recovery time, but no delay in discharge home.