Respiratory Tract InfectionNCT06936761
This Study Evaluated the Safety of Awake Extubation in Children at Risk for Respiratory Events Undergoing General Anesthesia.
An observational study of Respiratory Tract Infection, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to evaluate the safety of awake extubation in children at risk for PRAEs undergoing general anesthesia. Specifically, this study seeks to compare the effects of sevoflurane and propofol induction on postoperative (emergence and recovery) respiratory outcomes in these patients. Read more about this study
- Who is it for?
- Ages 2 to 13 years
- Conditions the study is for
- Respiratory Tract Infection
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- How many people
- 425 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 31 Dec 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 13 years
- All sexes
- No healthy volunteers
- Child
Study population: 425 children (aged 2 to 13) underwent elective dental rehabilitation under general anesthesia. During preoperative anesthesia evaluations, an anesthesia research nurse who was unaware of the study protocol administered a modified ISAAC (International Study of Asthma and Allergies in Childhood) questionnaire. The presence of one or more risk factors for PRAEs was recorded, including a cold or flu within the previous two weeks, wheezing more than three times in the past 12 months, wheezing during exercise, dry nocturnal cough, current or past eczema, two family members with asthma, two family members with eczema, two family members with hay fever, and smoking by the mother or both parents.
Who may be able to join
- At least have one criteria of the ISAAC questionnaire
- ASA1\&2
Who cannot join
- cardiac disease
- airway or thoracic malformations
- ASA3
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Dentistry
Konya, Selcuklu
About this study
Official title: Comparison of Two Induction Methods in Awake Extubated Children at Risk for Respiratory Adverse Events: A Retrospective Study
The primary aim of this study was to evaluate the safety of awake extubation in children at risk for PRAEs undergoing general anesthesia. Specifically, this study seeks to compare the effects of sevoflurane and propofol induction on postoperative (emergence and recovery) respiratory outcomes in these patients. This study aims to provide insights that could enhance anesthesia protocols in pediatric populations with heightened respiratory risks by identifying potential differences in airway-related adverse events between the two agents.
Read the detailed description
Awake extubation is advantageous in ambulatory settings where patients are discharged on the same day, as it reduces the risk of airway-related complications during recovery and ensures a smoother transition to postoperative care. When children come in for dental treatments requiring GA, they can face higher chances of respiratory issues due to things like colds, asthma, or unique physical traits. The way we introduce anesthesia is important in helping prevent these complications. In this context, sevoflurane and propofol are two commonly used agents for the induction of anesthesia in children. Sevoflurane, a volatile anesthetic agent, is favored for its non-irritating nature and smooth induction process, particularly in pediatric patients. However, its use has been associated with a higher incidence of airway complications, including laryngospasm and coughing. On the other hand, propofol, a widely used intravenous (IV) agent, is known for its rapid onset and favorable recovery profile. It also reduces airway reflex responses, potentially decreasing the risk of respiratory complications during induction and emergence.
Current evidence suggests that extubating during emergence from anesthesia does not significantly alter clinical outcomes for healthy children. A large prospective cohort study examined a population at particularly high risk for perioperative respiratory adverse events (PRAEs). Additionally, a detailed analysis of the risk factors within the cohort suggested that the timing of extubation seemed to impact the occurrence of laryngospasm and severe complications of coughing.
The primary aim of this study was to evaluate the safety of awake extubation in children at risk for PRAEs undergoing general anesthesia. Specifically, this study seeks to compare the effects of sevoflurane and propofol induction on postoperative (emergence and recovery) respiratory outcomes in these patients. By identifying potential differences in airway-related adverse events between the two agents, this study aims to provide insights that could enhance anesthesia protocols in pediatric populations with heightened respiratory risks.
All children were extubated while awake when they demonstrated facial grimacing, adequate tidal volumes, an appropriate respiratory rate, coughing with an open mouth, opening their eyes, and purposeful movements. The anesthesiologist placed all children on 100% oxygen prior to extubation and transported them in the lateral position to the Post-Anesthesia Care Unit (PACU) after ensuring they could maintain adequate airway patency. Oxygen saturation was continuously monitored until discharge from the PACU. Room air was administered unless saturation fell below 95%, at which point supplemental oxygen was provided. All incidents of laryngospasm, bronchospasm (serious risk factors; I, II), desaturation below 95%, airway obstruction, severe coughing, or postoperative stridor (minor risk factors; III, IV) were recorded, along with any airway interventions. The primary outcome measure for analysis was oxygen saturation below 95% for more than 10 seconds. However, shorter desaturation episodes were also captured since oxygen saturation was continuously recorded per institutional guidelines. Any treatment required in response to respiratory adverse events was documented.
Subsequently, the responsible anesthesiologist gathered and reviewed all relevant data from anesthesia and PACU records. Patients with known cardiac disease, airway, or thoracic malformations were excluded from the study.
- Conditions
- Respiratory Tract Infection
- Being tested
- Propofol, Sevoflurane
- Keywords
- awake extubation, general anesthesia, children, sevoflurane
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
This is an observational study about routines of anesthesia induction and extubation
SevofluraneDrug
Also called propofol
This is a retrospective evolution of anesthesia drugs used routinely in an anesthesia clinic.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane (8% in oxygen 2% and air 2%) | Inhaler induction with sevoflurane 8% in oxygen 2% and air 2%, intravenous induction with propofol (3-5 mg/kg) Receives: Drug: Sevoflurane | |
| propofol (3-5 mg/kg IV) | This is a retrospective study about rottenly used anesthesia drugs. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was defined as a drop in oxygen saturation (SpO₂) below 95% lasting longer than 10 seconds.
Room air was administered unless saturation fell below 95%, at which point supplemental oxygen was provided.
Measured: 10 sec
Serious risk factors (in ASA I and II patients): Laryngospasm Bronchospasm
Measured: 3 Hours in PACU
Minor Risk factors: Airway obstruction Severe coughing Postoperative stridor
Measured: 3 Hours in PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Dec 2024
- Primary completion25 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FUNDA ARUN, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936761
- Sponsor's protocol ID
- F005
- Other IDs
- 07/2024
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Induction Methods in Awake Extubated Children at Risk for Respiratory Adverse Events: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06936761
- Acronym / sponsor ID
- F005
- Conditions
- Respiratory Tract Infection
- Keywords
- awake extubation, general anesthesia, children, sevoflurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Apr 2025 (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.
The primary aim of this study was to evaluate the safety of awake extubation in children at risk for PRAEs undergoing general anesthesia. Specifically, this study seeks to compare the effects of sevoflurane and propofol induction on postoperative (emergence and recovery) respiratory outcomes in these patients. This study aims to provide insights that could enhance anesthesia protocols in pediatric populations with heightened respiratory risks by identifying potential differences in airway-related adverse events between the two agents.
Detailed description
Awake extubation is advantageous in ambulatory settings where patients are discharged on the same day, as it reduces the risk of airway-related complications during recovery and ensures a smoother transition to postoperative care. When children come in for dental treatments requiring GA, they can face higher chances of respiratory issues due to things like colds, asthma, or unique physical traits. The way we introduce anesthesia is important in helping prevent these complications. In this context, sevoflurane and propofol are two commonly used agents for the induction of anesthesia in children. Sevoflurane, a volatile anesthetic agent, is favored for its non-irritating nature and smooth induction process, particularly in pediatric patients. However, its use has been associated with a higher incidence of airway complications, including laryngospasm and coughing. On the other hand, propofol, a widely used intravenous (IV) agent, is known for its rapid onset and favorable recovery profile. It also reduces airway reflex responses, potentially decreasing the risk of respiratory complications during induction and emergence.
Current evidence suggests that extubating during emergence from anesthesia does not significantly alter clinical outcomes for healthy children. A large prospective cohort study examined a population at particularly high risk for perioperative respiratory adverse events (PRAEs). Additionally, a detailed analysis of the risk factors within the cohort suggested that the timing of extubation seemed to impact the occurrence of laryngospasm and severe complications of coughing.
The primary aim of this study was to evaluate the safety of awake extubation in children at risk for PRAEs undergoing general anesthesia. Specifically, this study seeks to compare the effects of sevoflurane and propofol induction on postoperative (emergence and recovery) respiratory outcomes in these patients. By identifying potential differences in airway-related adverse events between the two agents, this study aims to provide insights that could enhance anesthesia protocols in pediatric populations with heightened respiratory risks.
All children were extubated while awake when they demonstrated facial grimacing, adequate tidal volumes, an appropriate respiratory rate, coughing with an open mouth, opening their eyes, and purposeful movements. The anesthesiologist placed all children on 100% oxygen prior to extubation and transported them in the lateral position to the Post-Anesthesia Care Unit (PACU) after ensuring they could maintain adequate airway patency. Oxygen saturation was continuously monitored until discharge from the PACU. Room air was administered unless saturation fell below 95%, at which point supplemental oxygen was provided. All incidents of laryngospasm, bronchospasm (serious risk factors; I, II), desaturation below 95%, airway obstruction, severe coughing, or postoperative stridor (minor risk factors; III, IV) were recorded, along with any airway interventions. The primary outcome measure for analysis was oxygen saturation below 95% for more than 10 seconds. However, shorter desaturation episodes were also captured since oxygen saturation was continuously recorded per institutional guidelines. Any treatment required in response to respiratory adverse events was documented.
Subsequently, the responsible anesthesiologist gathered and reviewed all relevant data from anesthesia and PACU records. Patients with known cardiac disease, airway, or thoracic malformations were excluded from the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane (8% in oxygen 2% and air 2%) | – | Drug: SevofluraneInhaler induction with sevoflurane 8% in oxygen 2% and air 2%, intravenous induction with propofol (3-5 mg/kg) |
| propofol (3-5 mg/kg IV) | – | Drug: PropofolThis is a retrospective study about rottenly used anesthesia drugs. |
Who may qualify
- Ages
- 2 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 425 children (aged 2 to 13) underwent elective dental rehabilitation under general anesthesia. During preoperative anesthesia evaluations, an anesthesia research nurse who was unaware of the study protocol administered a modified ISAAC (International Study of Asthma and Allergies in Childhood) questionnaire. The presence of one or more risk factors for PRAEs was recorded, including a cold or flu within the previous two weeks, wheezing more than three times in the past 12 months, wheezing during exercise, dry nocturnal cough, current or past eczema, two family members with asthma, two family members with eczema, two family members with hay fever, and smoking by the mother or both parents.
Key inclusion criteria (2 listed)
- At least have one criteria of the ISAAC questionnaire
- ASA1\&2
Key exclusion criteria (3 listed)
- cardiac disease
- airway or thoracic malformations
- ASA3
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 |
|---|---|---|
| PropofolThis is an observational study about routines of anesthesia induction and extubation | Drug | propofol (3-5 mg/kg IV) |
| SevofluraneAlso: propofolThis is a retrospective evolution of anesthesia drugs used routinely in an anesthesia clinic. | Drug | Sevoflurane (8% in oxygen 2% and air 2%) |
Primary outcome
The primary outcome was defined as a drop in oxygen saturation (SpO₂) below 95% lasting longer than 10 seconds.
Time frame: 10 sec
Room air was administered unless saturation fell below 95%, at which point supplemental oxygen was provided.
Serious risk factors (in ASA I and II patients): Laryngospasm Bronchospasm
Time frame: 3 Hours in PACU
Minor Risk factors: Airway obstruction Severe coughing Postoperative stridor
Time frame: 3 Hours in PACU
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 20 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infection, run by Selcuk University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The primary outcome was defined as a drop in oxygen saturation (SpO₂) below 95% lasting longer than 10 seconds. (time frame: 10 sec). The study lists 3 primary outcomes in all. 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 20 Apr 2025.