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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06936761
Study groupRoleWhat 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.

  1. 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

  2. Serious risk factors (in ASA I and II patients): Laryngospasm Bronchospasm

    Measured: 3 Hours in PACU

  3. 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.

  1. First posted20 Apr 2025
  2. Study start1 Dec 2024
  3. Primary completion25 Dec 2024
  4. Study completion31 Dec 2024

Resources

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)
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

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.

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