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

NCT06694675 | Completed

• 1 other identifier: FirstHCMU-sevoflurane
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Sevoflurane; general anesthesia; RSV infection; pediatric patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inflammation response indications

  After induction of general anesthesia and intubation; at the end of anesthesia

Study Arms (2)

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

Sevoflurane (Volatile Anesthetic) DRUG

Sevoflurane 1%\~3.5%

Control group; RSV group

propofol DRUG

Propofol 9\~15mg/kg/h

Control group; RSV group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

80

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (2)

First hospital of China Mdical University

Shenyang, Liaoning, 110000, China

Location

First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tracheal secretions

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of anesthesiology department

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 19, 2024
• Study Start: February 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: January 31, 2024
• Last Updated: January 22, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)