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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04807998
Recruitment Status : Active, not recruiting
First Posted : March 19, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Description
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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
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
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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 : September 28, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Risk factors for pain and emergence agitation following maxillofacial surgery in children [ Time Frame: 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.

  2. The levels of serum and urine metabolites in EA [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Patients' blood and urine

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing palatopharyngoplasty/tonsillar and/or adenoidectomy, auricle reconstruction, and photodynamic therapy for vascular malformations on face.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807998


Locations
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China
Shanghai No.9 People's Hospital
Shanghai, China
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Study Chair: Jingjie Li, M.D Shanghai No.9 People's Hospital
More Information
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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: March 19, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
pediatric emergence agitation
postoperative Pain
metabolomics
Additional relevant MeSH terms:
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Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
 Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders