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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Emergence Agitation; Metabolomics; Pain

Study type: Observational

Funder types: Other

Identifiers

NCT04807998

SH9H-2020-T149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria in Part I

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.

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

Inclusion Criteria:

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 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.

Trial design

300 participants in 2 patient groups

Group EA

Description:

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

Description:

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.