Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Location status: Recruiting
NCT Number: NCT04091724
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.
Interested in participating?
Request InfoUp to 16 year
All sexes
Observational
Wuhan, Hubei, 430030, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
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: from stay at the preoperative holding room to discharge of the child from the Post-Anesthesia Care Unit, , an average of 3 hours
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: baseline (At the preoperative holding room)
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: Procedure (At the beginning of the Induction)
Measured by Induction compliance checklist (Kain et al. 1998).
Time frame: During the operation, an average of 1 hour
Systolic and diastolic blood pressures are assessed.
Time frame: During the operation, an average of 1 hour
Time frame: During the operation, an average of 1 hour
Time frame: During the anesthesia, an average of 1 hour
Time frame: During the operation
Time frame: During the operation, an average of 1 hour
Time frame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, , an average of 1 hour
Adverse events such as vomiting, cough, breath holding, laryngospasm, and oxygen desaturation are recorded
Time frame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
The level of consciousness is measured by Richmond Agitation Sedation Scale score (Kerson et al. 2016). The Richmond Agitation and Sedation Scale (RASS) is a 10-point scale, with four levels of anxiety or agitation, one level denoting a calm and alert state, and 5 levels of sedation.
Time frame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
Postoperative pain is measured by the FLACC- Scale (Merkel et al. 1997). The Face, Legs, Activity, Cry, Consolability (FLACC ) scale is a measurement used to assess pain for children or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Time frame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
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 hour
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: During the stay in the Post-Anesthesia Care Unit, an average of 1 hour
When patients become calm and meet a modified Aldrete score (Aldrete et al. 1995) ≥ 9, they are discharged and the duration of the PACU stay is recorded as the PACU stay time.
Time frame: Up to 30 postoperative days
The behavioral problem is measured by a modified Version of the Posthospital Behavior Questionnaire (PHBQ) (Stargatt et al. 2006)
Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days.
Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days.
Contact information is provided by the study sponsor or research team.
Huazhong University of Science and Technology
Other
Perioperative EEG-Monitoring and Emergence Delirium in Children: a Prospective Observational Study
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