Perioperative EEG-Monitoring and Emergence Delirium in Children

Recruiting

• Conditions: Delirium

• Registration Number: NCT04091724
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-17
• Study Start: 2019-12-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. male or female children aged under 16 years
2. planned elective surgery
3. informed consent by parents or legal guardians

Exclusion Criteria

1. history of neurological or psychiatric disease
2. delayed development
3. inability of the parents or legal guardians to speak or read Chinese
4. participation in another prospective interventional clinical study during this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Compliance of the children during induction	Procedure (At the beginning of the Induction)	Measured by Induction compliance checklist (Kain et al. 1998).
Body temperature	During the operation, an average of 1 hour
Duration of anesthesia	During the anesthesia, an average of 1 hour
Blood pressure	During the operation, an average of 1 hour	Systolic and diastolic blood pressures are assessed.
Type of surgery	During the operation
Heart rate	During the operation, an average of 1 hour
Duration of surgery	During the operation, an average of 1 hour
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.
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.
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
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.
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.
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)

Trial Locations

Locations (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China