Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perioperative EEG-Monitoring and Emergence Delirium in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091724
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Hua Zheng, 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.

Condition or disease
Delirium

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative EEG-Monitoring and Emergence Delirium in Children: a Prospective Observational Study
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort
Delirium is determined by PAED score
No delirium is determined by PAED score



Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children for elective surgery aged under 16 years
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091724


Contacts
Layout table for location contacts
Contact: Hua Zheng, M.D. 0086-27-83663173 hzheng@hust.edu.cn

Locations
Layout table for location information
China, Hubei
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

Publications:
Layout table for additonal information
Responsible Party: Hua Zheng, Principal Investigator, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT04091724     History of Changes
Other Study ID Numbers: TJMZK201901
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes