Perioperative EEG-Monitoring and Emergence Delirium in Children
ConditionDelirium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 16
SponsorHuazhong University of Science and Technology
About this trial
Emergence delirium is a significant problem, particularly in children. However the incidence, preventative strategies, and management of emergence delirium remain unclear. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of emergence delirium in children under 16 years scheduled for elective surgery using electroencephalogram. The "Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" (Sikich et al. 2004) is used to screen for the occurrence of emergence delirium in the post anesthesia care unit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
male or female children aged under 16 years
planned elective surgery
informed consent by parents or legal guardians
Disqualifiers
history of neurological or psychiatric disease
delayed development
inability of the parents or legal guardians to speak or read Chinese
participation in another prospective interventional clinical study during this study
Trial population
Children for elective surgery aged under 16 years
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: Delirium is determined by PAED score
Group B: No delirium is determined by PAED score
Trial outcomes
Primary outcomes
1
Incidence of emergence delirium
The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004).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. A peak PAED value ≥ 10 is considered emergence delirium.
Time frame
Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hourSecondary outcomes
1
Relative power of each brain waves
Electroencephalogram data were acquired using a 32-channel electroencephalogram recording system (Brain Products, Germany). A 5 min, baseline, eyes-closed recording was conducted at the preoperative holding room when the child was at rest. Recording of electroencephalogram was commenced before the start of anesthetic induction and was stopped before discharge of the child from the Post-Anesthesia Care Unit. We defied delta (1 to 3 Hz), theta (4 to 7 Hz), alpha (8 to 12 Hz), and beta (13 to 40 Hz) frequency bands. And then, the relative power of each frequency bands to the total power of the sum is calculated.
Time frame
from stay at the preoperative holding room to discharge of the child from the Post-Anesthesia Care Unit, , an average of 3 hours2
Preoperative anxiety of children
Preoperative anxiety is evaluated using the preoperative modified Yale Preoperative Anxiety Scale (m-YPAS) score (Kain et al. 1997). The modified Yale Preoperative Anxiety Scale (m-YPAS) consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parent). Children's behavior is rated from 1 to 4 or 1 to 6 (depending on the item), with higher numbers indicating the highest severity within that item. Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100. This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety.
Time frame
baseline (At the preoperative holding room)3
Compliance of the children during induction
Measured by Induction compliance checklist (Kain et al. 1998).
Time frame
Procedure (At the beginning of the Induction)4
Blood pressure
Systolic and diastolic blood pressures are assessed.
Time frame
During the operation, an average of 1 hourSponsors and contacts
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Source ClinicalTrials.gov