RSV Infection in Children Less Than 5 Years of AgeNCT06694675
The Effect of Sevoflurane on Airway Hyperreactivity During the Perioperative Period.
An observational study of RSV Infection in Children Less Than 5 Years of Age and General Anesthesia, run by First Hospital of China Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- RSV Infection in Children Less Than 5 Years of Age, General Anesthesia
- What is being tested?
- Sevoflurane (Volatile Anesthetic) and propofol
- How many people
- 97 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2022to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 80
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
First hospital of China Mdical University
Shenyang, Liaoning, 110000
First Hospital of China Medical University
Shenyang, Liaoning, 110000
About this study
Official title: 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.
- Being tested
- Sevoflurane (Volatile Anesthetic), propofol
- Keywords
- Sevoflurane, general anesthesia, RSV infection, pediatric patients
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane (Volatile Anesthetic)Drug
Sevoflurane 1%~3.5%
propofolDrug
Propofol 9~15mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sevoflurane (Volatile Anesthetic); Drug: propofol | |
| RSV group | The nasopharyngeal swab of the RSV antigen test is positive. Receives: Drug: Sevoflurane (Volatile Anesthetic); Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative ventilator parameters
Airway pressure(including Paw, PIP, Pplat), and pulmonary compliance.
Measured: After induction of general anesthesia and intubation; at the end of anesthesia
Secondary outcomes (1)
Inflammation response indications
The level of NLRP3 and IL-1β measured by ELISA in the tracheal secretions of the patients
Measured: After induction of general anesthesia and intubation; at the end of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Feb 2022
- Primary completion31 Aug 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV Infection in Children Less Than 5 Years of AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Weiwei, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694675
- Sponsor's protocol ID
- FirstHCMU-sevoflurane
- Status last verified
- Oct 2024
- First submitted
- 16 Nov 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Effect of Sevoflurane on Airway Hyperreactivity in Children with RSV Infection During the Perioperative Period.
- ClinicalTrials.gov ID
- NCT06694675
- Acronym / sponsor ID
- FirstHCMU-sevoflurane
- Keywords
- Sevoflurane, general anesthesia, RSV infection, pediatric patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Drug: Sevoflurane (Volatile Anesthetic), Drug: propofolThe 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 | – | Drug: Sevoflurane (Volatile Anesthetic), Drug: propofolThe nasopharyngeal swab of the RSV antigen test is positive. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 80
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane (Volatile Anesthetic)Sevoflurane 1%~3.5% | Drug | Control group, RSV group |
| propofolPropofol 9~15mg/kg/h | Drug | Control group, RSV group |
Primary outcome
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.
1 secondary outcome
Inflammation response indications
Time frame: After induction of general anesthesia and intubation; at the end of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infection in Children Less Than 5 Years of Age and General Anesthesia, run by First Hospital of China Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative ventilator parameters (time frame: After induction of general anesthesia and intubation; at the end of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.