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Recruiting NCT04091724

Perioperative EEG-Monitoring and Emergence Delirium in Children

— Observational Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Delirium. Basic parameters: up to 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]
  • Preoperative anxiety of children [Time frame: baseline (At the preoperative holding room)]
  • Compliance of the children during induction [Time frame: Procedure (At the beginning of the Induction)]
  • Blood pressure [Time frame: During the operation, an average of 1 hour]
  • Heart rate [Time frame: During the operation, an average of 1 hour]
  • Body temperature [Time frame: During the operation, an average of 1 hour]
  • Duration of anesthesia [Time frame: During the anesthesia, an average of 1 hour]
  • Type of surgery [Time frame: During the operation]
  • Duration of surgery [Time frame: During the operation, an average of 1 hour]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong Univers — Wuhan

Publications

  • Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015. PMID 15114210
  • 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. doi: 10.1097/00000539-199710000-00012. PMID 9322455
  • 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. doi: 10.1097/00000542-199811000-00015. PMID 9822003
  • 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. PMID 9220806
  • 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. doi: 10.1111/j.1460-9592.2006.01869.x. PMID 16884468
  • 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. doi: 10.1186/s40560-016-0189-5. eCollection 2016. PMID 27800163

Identifiers

NCT: NCT04091724 · TJMZK201901

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗