Introduction
Emergence delirium (ED)
is an acute brain dysfunction during recovery from general anesthesia. It can
be complicated by varying levels of consciousness and encompasses disruptive
behaviors that almost always require intervention during the postoperative period.
Pediatric emergence
delirium (paedED)is seen most commonly in children between the ages of 2- 8
years and may present with purposelessness, disorientation,
decreased awareness of surrounding, staring or averting of eyes from caregivers
and inconsolability.
PaedED continues to be a
matter of concern in perioperative care and its varied incidence (2%-80%) is influenced by a wide range of risk factors, including preoperative
parental and child anxiety, use of volatile anesthetic, type of surgery and
untreated pain.
Children experiencing ED
are associated with an increased risk of injuring themselves, their caregivers
and their surgical repair, displacing intravenous lines, catheters, drains. ED
leads to increased length of stays and constant supervision in post-anesthesia
care unit (PACU), which puts a strain on healthcare resources indicating the need for better preventive and curative measures. In addition, it was seen that children with PaedED were 1.43 times at greater
risk of having long term maladaptive behavioral changes.
Pharmacological methods
like alpha 2 agonists(dexmedetomidine), opioids, melatonin, midazolam, ketamine
and magnesium, when used in conjunction with volatile anesthetics have been
shown to reduce the incidence and severity of emergence delirium. However, children may experience side effects such as hypotension, bradycardia,
sedation with the use of these medications.
Emergence delirium in
children has also been addressed using non pharmacological approaches. Some of
these methods include parental presence, cartoons, handheld video games during
induction, and have proven to be comparable to medications in reducing the
incidence of ED
Studies have shown that
listening to a mother’s voice postoperatively reduces emergence delirium
compared to those hearing a stranger’s voice, suggesting a comforting role of
familiar voices.
However,
since the mother may not always be present or the primary caregiver, we chose to
examine the impact of the closest caregiver’s voice on emergence delirium. Methodology:
The children who fulfill the
inclusion criteria and are posted for elective surgery will be screened for the
study. Informed consent will be taken from the parent. For children aged 7-8
years, assent will be obtained in addition to the parental consent. We will
explain the study in an age-appropriate language, using simple verbal
explanations or visual aids (pictures and headphones).The child’s agreement
will be documented on an assent form. For children between 2-6 years, formal
assent is not required but we will explain the study in an age-appropriate
manner to ensure the child’s comfort and to minimize distress. A thorough
Pre-anesthetic checkup (PAC) will be done one day prior to the proposed
surgery. The patient will be kept nil per oral for 6 hours pre operatively for solids,
and 2 hours for clear fluids, as per existing fasting guidelines.
On the day
of the surgery, randomisation and voice recording will be done by an
independent assessor who is an anaesthesiologist. The anaesthesiologist in the
OT will be blinded to the group allocation and will perform the study. The caregiver and the
anesthesiologist (independent assessor) will be asked to speak the following
sentences in their usual tone of voice and in the
language that is spoken/understood by the child. “Wake up (name of the child).
Open your eyes, breathe well. Wake up, (name of the child) It is time to go
home. Wake up (name of child).”
The participants will be randomized
to one of two groups with a 1:1 ratio-Group C participants will be made to
listen to the recorded voice of the caregiver and Group A will be made to
listen to the recorded voice of the
Anesthesiologist. The randomization
will be done using the random number generator tool available on Google. In
case an odd number is generated the participant will be part of Group A and if
an even number is generated, the participant will be part of Group C.
We will
assess the preoperative anxiety in the child in the pre-op area using the
modified Yale preoperative anxiety scale for children (m-YPAS). We calculate the m-YPAS score by dividing
each domain score by the highest possible score (i.e., 6 for the
“vocalizations” domain and 4 for all other items), add all of the produced
values, divide by 4, and multiply by 100. This produces a score ranging from
22.92 to 100, with higher values indicating greater anxiety. After entering the operating
theatre, standard monitoring equipment (non-invasive arterial blood pressure,
electrocardiography, heart rate, pulse oximetry and end tidal CO2) will be
connected to the patient. Baseline recording will be noted.
Premedication will be administered
with Glycopyrrolate 10mcg/kg IV. Ondansetron 0.15mg/kg IV and midazolam 0.03
mg/kg IV. Anesthesia will be induced with Inj. Fentanyl 2mcg/kg. Propofol
2mg/kg IV. Atracurium(0.5 mg/kg IV)will be administered and ventilation will be
done with a bag and mask for 3 minutes. This will be followed by direct
laryngoscopy and intubation with an appropriate-sized Macintosh blade and
endotracheal tube respectively. Anaesthesia will be maintained on 50%
air-oxygen mixture and sevoflurane titrated and kept to MAC between 1.0 and
1.2. Regular intervals of Atracurium (0.1mg/kg IV) will be given to maintain
neuromuscular blockade.In case of infra umblical surgeries, caudal analgesia
with 0.25% Bupivacaine(1ml/kg) will be given.Intermittent Fentanyl boluses(0.5
mcg/kg) will be given for all other surgeries. Paracetamol 10mg/kg will also be
given IV for all surgeries for analgesia.
The recorded voice of the caregiver
(Group C) or the anaesthesiologist( Group A) will be delivered through
noise cancelling headphones at the
end of the surgery and will be repeated every 20 seconds until the patient
has entered the PACU. The volume
will be set to a normal speech level and the patient will be stimulated to
wake up by lightly patting on the shoulder.
No other stimulation is allowed.
The effect of Atracurium will be
reversed using Neostigmine (0.05 mg/kg IV) and Glycopyrrolate (10 mcg/kg IV)
and the oral cavity secretions will be gently suctioned and the child will be
extubated once the extubation criteria has been met.
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