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

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04807998

Collaborator

(none)

300

Enrollment

Location

14.1

Anticipated Duration (Months)

21.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Emergence Agitation Pain Metabolomics

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Risk Factors for Pediatric Emergence Agitation and Post-operative Pain Following Maxillofacial Surgery and Analysis of Serum or Urine Metabonomics in Children With Agitation-An Exploratory Study

Actual Study Start Date :

Sep 28, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

Risk factors for pain and emergence agitation following maxillofacial surgery in children [within 48 hours]
Children aged 3-12 years who undergoing palatopharyngoplasty/adenoidectomy or adenotonsillectomy, auricle reconstruction, and photodynamic therapy for vascular malformations were enrolled in this study. The general information of children, preoperative anxiety state, preoperative anxiety state of parents, operation type, anesthesia method, analgesic drug, postoperative pain and emergence agitation degree were collected. Multivariate regression analysis were conducted to identify the risk factors for pain and emergence agitation following maxillofacial surgery in children.
The levels of serum and urine metabolites in EA [within 24 hours]
Children who underwent adenoidectomy or adenotonsillectomy in part I of this study were included. Urine (5ml) and peripheral venous blood (1ml) samples were collected before anesthesia and immediately after completion of agitation score. EA was defined as a Pediatric anesthesia emergence delirium(PAED) score ≥12 points. Children in EA group were matched with non-EA group, and UPLC-Q TOF/MS analysis was performed to identify the metabolites between two groups during the recovery period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Eligibility Criteria in Part I

Inclusion Criteria:

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

Exclusion Criteria:

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

Eligibility Criteria in Part II

Inclusion Criteria:

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

Exclusion Criteria:

Patients with developmental delays or mental disorders.
Patients with neurological or psychiatric diseases.
Patients with severe liver and kidney damage,or other heart and lung disease.
Patients with metabolic diseases or family inherited diseases.
Patients who received drug treatment or intravenous nutritional supports.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai No.9 People's Hospital	Shanghai		China

Sponsors and Collaborators

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

Investigators

Study Chair: Jingjie Li, M.D, Shanghai No.9 People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jingjie Li, vice-director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

ClinicalTrials.gov Identifier:

NCT04807998

Other Study ID Numbers:

SH9H-2020-T149

First Posted:

Mar 19, 2021

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jingjie Li, vice-director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

pediatric emergence agitation

postoperative Pain

metabolomics

Additional relevant MeSH terms:

Psychomotor Agitation

Emergence Delirium

Study Results

No Results Posted as of Nov 19, 2021