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

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

Study Overview

• Status: Completed
• Conditions: General Anesthesia; RSV Infection in Children Less Than 5 Years of Age
• Intervention / Treatment: Drug: Sevoflurane (Volatile Anesthetic); Drug: propofol

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • First Hospital of China Medical University
    • Shenyang, Liaoning, China, 110000
      • First hospital of China Mdical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

80

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Sevoflurane (Volatile Anesthetic); Sevoflurane 1%~3.5%; Drug: propofol; Propofol 9~15mg/kg/h
RSV group; The nasopharyngeal swab of the RSV antigen test is positive.	Drug: Sevoflurane (Volatile Anesthetic); Sevoflurane 1%~3.5%; Drug: propofol; Propofol 9~15mg/kg/h

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation response indications	The level of NLRP3 and IL-1β measured by ELISA in the tracheal secretions of the patients	After induction of general anesthesia and intubation; at the end of anesthesia

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: November 16, 2024
• First Submitted That Met QC Criteria: November 16, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: general anesthesia; Sevoflurane; pediatric patients; RSV infection
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Infections; Respiratory Syncytial Virus Infections; Physiological Effects of Drugs; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Anesthetics, Inhalation; Sevoflurane; Anesthetics; Propofol
• Other Study ID Numbers: FirstHCMU-sevoflurane

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No