Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04091724

Perioperative EEG-Monitoring and Emergence Delirium in Children

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female children aged under 16 years
  • planned elective surgery
  • informed consent by parents or legal guardians

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Incidence of 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.

Secondary outcomes

  1. Relative power of each brain waves

    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.

  2. Preoperative anxiety of children

    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.

  3. Compliance of the children during induction

    Time frame: Procedure (At the beginning of the Induction)

    Measured by Induction compliance checklist (Kain et al. 1998).

  4. Blood pressure

    Time frame: During the operation, an average of 1 hour

    Systolic and diastolic blood pressures are assessed.

  5. Heart rate

    Time frame: During the operation, an average of 1 hour

  6. Body temperature

    Time frame: During the operation, an average of 1 hour

  7. Duration of anesthesia

    Time frame: During the anesthesia, an average of 1 hour

  8. Type of surgery

    Time frame: During the operation

  9. Duration of surgery

    Time frame: During the operation, an average of 1 hour

  10. Number of Participants with adverse events

    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

  11. The level of consciousness

    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.

  12. Postoperative pain: FLACC- Scale

    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.

  13. Severity of 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.

  14. Duration of 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.

  15. Post-Anesthesia Care Unit (PACU) stay time

    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.

  16. Incidence of behavioral problem

    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)

  17. Number of Participants with postoperative organ complications

    Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days.

  18. Hospital length of stay

    Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Zheng, M.D.

CONTACT

[email protected]

0086-27-83663173

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

Perioperative EEG-Monitoring and Emergence Delirium in Children: a Prospective Observational Study

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Sep 17, 2019
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.