Perioperative EEG-Monitoring and Emergence Delirium in Children

NCT04091724 | Recruiting

• 1 other identifier: TJMZK201901
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of emergence delirium

  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.

  Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour

Secondary Outcomes (18)

• 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

• Preoperative anxiety of children

  baseline (At the preoperative holding room)

• Compliance of the children during induction

  Procedure (At the beginning of the Induction)

• Blood pressure

  During the operation, an average of 1 hour

• Heart rate

  During the operation, an average of 1 hour

Study Arms (2)

Delirium is determined by PAED score

No delirium is determined by PAED score

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children for elective surgery aged under 16 years

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Hua Zheng, M.D.

CONTACT

0086-27-83663173; hzheng@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 17, 2019
• Study Start: December 2, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (1)