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Risk Factors for Pediatric Emergence Agitation and Analysis of Serum or Urine Metabonomics in Children With Agitation

NCT ID: NCT04807998

Last Updated: 2021-11-19

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

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-28

Study Completion Date

2021-12-31

Brief Summary

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It is known that some factors are associated with emergence agitation(EA), and investigators are still unable to predict accurately those who undergoing maxillofacial surgery are at great risks.This study intend to identify the risk factors for EA and to explore the mechanism of EA , which is helpful for early prediction, prevention and treatment in children.

Detailed Description

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This study was divided into two parts. The first part, multivariate regression analysis were conducted to identify the risk factors for pain and EA following maxillofacial surgery in children. The second part, metabolomics research was used to explore the relationship between metabolites and EA in children.

Conditions

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Emergence Agitation Pain Metabolomics

Keywords

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pediatric emergence agitation postoperative Pain metabolomics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group EA

Serum and Urine samples were collected before anesthesia and immediately after surgery from children who enrolled in part I and undergoing the adenoidectomy or adenotonsillectomy. A PAED score of 12 or greater was defined as EA. The serum and urine samples were analyzed by UHPLC-Q-TOF/MS separately.

No interventions assigned to this group

Group non-EA

Serum and Urine samples were collected before anesthesia and immediately after surgery from children who enrolled in part I and undergoing the adenoidectomy or adenotonsillectomy. A PAED score less than 12 was defined as non-EA. The serum and urine samples were analyzed by UHPLC-Q-TOF/MS separately.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing palatopharyngoplasty/tonsillar and/or adenoidectomy, auricle reconstruction, and photodynamic therapy for vascular malformations on face.
2. Aged between 3 years and 12 years.
3. American Society of Anesthesiologists(ASA) class I-II.


1. Patients who underwent adenoidectomy or adenotonsillectomy in part I of this study.
2. Aged between 3 years and 7 years.
3. American Society of Anesthesiologists(ASA) class I-II.
4. Patients who underwent sevoflurane anesthesia maintainance.

Exclusion Criteria

1. Patients with developmental delays.
2. Patients with mental disorders.
3. Patients with severe liver and kidney damage,or other heart and lung disease.
4. Reject to participate in the trials.

Eligibility Criteria in Part II


1. Patients with developmental delays or mental disorders.
2. Patients with neurological or psychiatric diseases.
3. Patients with severe liver and kidney damage,or other heart and lung disease.
4. Patients with metabolic diseases or family inherited diseases.
5. Patients who received drug treatment or intravenous nutritional supports.
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role lead

Responsible Party

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Jingjie Li

vice-director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jingjie Li, M.D

Role: STUDY_CHAIR

Shanghai No.9 People's Hospital

Locations

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Shanghai No.9 People's Hospital

Shanghai, , China

Site Status

Countries

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China

References

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Li Y, Li J, Shi Y, Zhou X, Feng W, Han L, Ma D, Jiang H, Yuan Y. Urinary Aromatic Amino Acid Metabolites Associated With Postoperative Emergence Agitation in Paediatric Patients After General Anaesthesia: Urine Metabolomics Study. Front Pharmacol. 2022 Jul 19;13:932776. doi: 10.3389/fphar.2022.932776. eCollection 2022.

Reference Type DERIVED
PMID: 35928271 (View on PubMed)

Other Identifiers

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SH9H-2020-T149

Identifier Type: -

Identifier Source: org_study_id