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Completed

NCT Number: NCT06694675

The Effect of Sevoflurane on Airway Hyperreactivity During the Perioperative Period.

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.

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Key information

Conditions

RSV Infection in Children Less Than 5 Years of Age General Anesthesia Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Hospital of China Medical University, Shenyang, Liaoning, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sevoflurane (Volatile Anesthetic)

Drug

Sevoflurane 1%~3.5%

Propofol

Drug

Propofol 9~15mg/kg/h

Primary outcomes

  1. 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

  1. Inflammation response indications

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

    The level of NLRP3 and IL-1β measured by ELISA in the tracheal secretions of the patients

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 19, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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