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

Completed

• Conditions: RSV Infection in Children Less Than 5 Years of Age; General Anesthesia
• Interventions: Drug: Sevoflurane (Volatile Anesthetic); Drug: propofol

• Registration Number: NCT06694675
• Lead Sponsor: First Hospital of China Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2023-08-31
• Study Completion: 2024-01-31
• Status Verified: 2024-10
• Study First Submitted: 2024-11-16
• Study First Submitted QC: 2024-11-16
• Study First Posted: 2024-11-19
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

1. Patients voluntarily joined this study and signed an informed consent form；
2. Age: 2-5 years old；
3. 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;
4. Plan to undergo elective adenoidectomy or adenotonsillectomy with tracheal intubation.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Sevoflurane (Volatile Anesthetic)	The nasopharyngeal swab test for RSV antigen was negative for patients with no history of respiratory infection in the past six weeks before surgery.
Control group	propofol	The nasopharyngeal swab test for RSV antigen was negative for patients with no history of respiratory infection in the past six weeks before surgery.
RSV group	Sevoflurane (Volatile Anesthetic)	The nasopharyngeal swab of the RSV antigen test is positive.
RSV group	propofol	The nasopharyngeal swab of the RSV antigen test is positive.

Primary Outcome Measures

Name	Time	Method
Intraoperative ventilator parameters	After induction of general anesthesia and intubation; at the end of anesthesia	Airway pressure(including Paw, PIP, Pplat), and pulmonary compliance.

Secondary Outcome Measures

Name	Time	Method
Inflammation response indications	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

Trial Locations

Locations (2)

First hospital of China Mdical University; 🇨🇳 Shenyang, Liaoning, China

First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China