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Clinical Trials/NCT06694675
NCT06694675
Completed
Not Applicable

An Observational Study on the Effect of Sevoflurane on Airway Hyperreactivity in Children with RSV Infection During the Perioperative Period.

First Hospital of China Medical University2 sites in 1 country97 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Sevoflurane (Volatile Anesthetic)
Conditions
Not specified
Sponsor
First Hospital of China Medical University
Enrollment
97
Locations
2
Primary Endpoint
Intraoperative ventilator parameters
Status
Completed
Last Updated
last year

Overview

Brief Summary

To investigate the effects of sevoflurane on respiratory parameters and respiratory inflammation in healthy and RSV-infected under general anesthesia and to propose suitable perioperative airway protection measures for children with respiratory virus infection undergoing general anesthesia.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
January 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
First Hospital of China Medical University
Responsible Party
Principal Investigator
Principal Investigator

Liu Weiwei

associate professor of anesthesiology department

First Hospital of China Medical University

Eligibility Criteria

Inclusion Criteria

  • Patients voluntarily joined this study and signed an informed consent form;
  • Age: 2-5 years old;
  • The patient should have a good general condition and no serious internal medicine comorbidities (ASA classification of the American Anesthesiology Association is Grade I); BMI ≤ 20;
  • Plan to undergo elective adenoidectomy or adenotonsillectomy with tracheal intubation.

Exclusion Criteria

  • Children with a history of allergic asthma;
  • Children with space-occupying lesions of the chest and lungs, or acute bronchiolitis or pneumonia;
  • Children with cardiovascular diseases that may cause cough, wheezing, and other symptoms;
  • Children who used leukotriene modulators, β2 receptor agonists, anticholinergics, theophyllines, or hormonal treatment drugs within two weeks;
  • Children allergic to propofol, sevoflurane, or other anesthetic agents;
  • Children with a family history of malignant hyperthermia;
  • Children with liver and kidney dysfunction;
  • The result of rapid antigen detection and nucleic acid test for RSV was inconsistent, or children combined with pathogen infections other than RSV;
  • Children with fever.

Arms & Interventions

Control group

The nasopharyngeal swab test for RSV antigen was negative for patients with no history of respiratory infection in the past six weeks before surgery.

Intervention: Sevoflurane (Volatile Anesthetic)

Control group

The nasopharyngeal swab test for RSV antigen was negative for patients with no history of respiratory infection in the past six weeks before surgery.

Intervention: propofol

RSV group

The nasopharyngeal swab of the RSV antigen test is positive.

Intervention: Sevoflurane (Volatile Anesthetic)

RSV group

The nasopharyngeal swab of the RSV antigen test is positive.

Intervention: propofol

Outcomes

Primary Outcomes

Intraoperative ventilator parameters

Time Frame: After induction of general anesthesia and intubation; at the end of anesthesia

Airway pressure(including Paw, PIP, Pplat), and pulmonary compliance.

Secondary Outcomes

  • Inflammation response indications(After induction of general anesthesia and intubation; at the end of anesthesia)

Study Sites (2)

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