Perioperative EEG-Monitoring and Emergence Delirium in Children

NCT ID: NCT04091724

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-02

Study Completion Date

2026-01-31

Brief Summary

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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

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Conditions

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Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Delirium is determined by PAED score

No interventions assigned to this group

No delirium is determined by PAED score

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Hua Zheng

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Zheng, M.D.

Role: CONTACT

0086-27-83663173

Facility Contacts

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Hua Zheng

Role: primary

0086-27-83663173

References

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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.

Reference Type BACKGROUND
PMID: 15114210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9322455 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9822003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9220806 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16884468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27800163 (View on PubMed)

Other Identifiers

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TJMZK201901

Identifier Type: -

Identifier Source: org_study_id

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