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

NCT04807998 | Unknown DMC

• 1 other identifier: SH9H-2020-T149
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation; Pain; Metabolomics

Keywords

pediatric emergence agitation; postoperative Pain; metabolomics

Outcome Measures

Primary Outcomes (2)

• Risk factors for pain and emergence agitation following maxillofacial surgery in children

  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.

  within 48 hours

• The levels of serum and urine metabolites in EA

  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.

  within 24 hours

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients undergoing palatopharyngoplasty/tonsillar and/or adenoidectomy, auricle reconstruction, and photodynamic therapy for vascular malformations on face.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai No.9 People's Hospital

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 35928271 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patients' blood and urine

MeSH Terms

Conditions

Emergence Delirium; Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jingjie Li, M.D

  Shanghai No.9 People's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-director

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: March 19, 2021
• Study Start: September 28, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)