Perioperative EEG-Monitoring and Emergence Delirium in Children
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Delirium is determined by PAED score
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| No delirium is determined by PAED score
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Outcome Measures
Primary Outcome Measures
- Incidence of emergence delirium [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.
Secondary Outcome Measures
- Relative power of each brain waves [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.
- Preoperative anxiety of children [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.
- Compliance of the children during induction [Procedure (At the beginning of the Induction)]
Measured by Induction compliance checklist (Kain et al. 1998).
- Blood pressure [During the operation, an average of 1 hour]
Systolic and diastolic blood pressures are assessed.
- Heart rate [During the operation, an average of 1 hour]
- Body temperature [During the operation, an average of 1 hour]
- Duration of anesthesia [During the anesthesia, an average of 1 hour]
- Type of surgery [During the operation]
- Duration of surgery [During the operation, an average of 1 hour]
- Number of Participants with adverse events [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
- The level of consciousness [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.
- Postoperative pain: FLACC- Scale [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.
- Severity of emergence Delirium [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.
- Duration of emergence Delirium [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.
- Post-Anesthesia Care Unit (PACU) stay time [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.
- Incidence of behavioral problem [Up to 30 postoperative days]
The behavioral problem is measured by a modified Version of the Posthospital Behavior Questionnaire (PHBQ) (Stargatt et al. 2006)
- Number of Participants with postoperative organ complications [Participants will be followed for the duration of hospital stay, an average of 5 days.]
- Hospital length of stay [Participants will be followed for the duration of hospital stay, an average of 5 days.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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male or female children aged under 16 years
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planned elective surgery
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informed consent by parents or legal guardians
Exclusion Criteria:
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history of neurological or psychiatric disease
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delayed development
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inability of the parents or legal guardians to speak or read Chinese
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participation in another prospective interventional clinical study during this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China | 430030 |
Sponsors and Collaborators
- Huazhong University of Science and Technology
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8.
- Kain ZN, Mayes LC, Wang SM, Caramico LA, Hofstadter MB. Parental presence during induction of anesthesia versus sedative premedication: which intervention is more effective? Anesthesiology. 1998 Nov;89(5):1147-56; discussion 9A-10A.
- Kerson AG, DeMaria R, Mauer E, Joyce C, Gerber LM, Greenwald BM, Silver G, Traube C. Validity of the Richmond Agitation-Sedation Scale (RASS) in critically ill children. J Intensive Care. 2016 Oct 26;4:65. eCollection 2016.
- Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45.
- Stargatt R, Davidson AJ, Huang GH, Czarnecki C, Gibson MA, Stewart SA, Jamsen K. A cohort study of the incidence and risk factors for negative behavior changes in children after general anesthesia. Paediatr Anaesth. 2006 Aug;16(8):846-59.
- TJMZK201901