CompletedNCT06694675Updated Jan 22, 2025

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

An observational study in RSV Infection in Children Less Than 5 Years of Age and General Anesthesia, sponsored by First Hospital of China Medical University. Completed at 2 sites in China. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by First Hospital of China Medical University · Observational

Study type: Observational
Model: Cohort
Time perspective: Cross-sectional
Enrollment: 97
Ages: 2 Years to 5 Years
Sex: All

Study 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.

Conditions studied

RSV Infection in Children Less Than 5 Years of Age
General Anesthesia

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Keywords

Sevoflurane
general anesthesia
RSV infection
pediatric patients

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 97 is below the median of 240 across 2,136 observational studies indexed under Infections.

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Lead sponsor

First Hospital of China Medical University is the lead sponsor of 59 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 5 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

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

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.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Enrollment: 97 participants (actual)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

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) · Drug: propofol
RSV group
The nasopharyngeal swab of the RSV antigen test is positive.
Drug: Sevoflurane (Volatile Anesthetic) · Drug: propofol

Interventions

DrugSevoflurane (Volatile Anesthetic)
Sevoflurane 1%\~3.5%
Drugpropofol
Propofol 9\~15mg/kg/h

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

2 sites

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06694675
Lead sponsor: First Hospital of China Medical University
Responsible party: Liu Weiwei (associate professor of anesthesiology department, First Hospital of China Medical University) — Principal investigator
First posted: Nov 19, 2024
Start date: Feb 1, 2022
Primary completion: Aug 31, 2023
Completion: Jan 31, 2024
Last update: Jan 22, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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