Pediatric SedationNCT04483258
Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients
A study testing Sedation with sevoflurane insufflation and intravenous sedation in people with Pediatric Sedation and Radiotherapy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy patients Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Pediatric Sedation, Radiotherapy, Inhalation Anesthesia
- What is being tested?
- Sedation with sevoflurane insufflation and intravenous sedation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2020to 30 Dec 2020
- Phase
- Interventional
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- undergoing radiotherapy session
Who cannot join
- family refusal
- chronic nausea and vomiting
- apnea history, pneumonia, asthma, bronchiolitis etc. respiratory tract infection or diseases
- cardiac disease
- kidney failure
- liver failure
Show all 9Show fewer
- anticipated difficult airway
- metabolic diseases
- neurological or muscular diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara, 06800
İsmail Aytac, +905056340369, aytacismail1972@gmail.com
About this study
Official title: Cross-over Analysis of Sevoflurane Insufflation and Intravenous Sedation for Radiotherapy in Pediatric Patients
aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy patients
Read the detailed description
aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy(RT) patients in terms of success of the procedure (continuous completion of the RT session by providing inactivity) and complications such as desaturation, hypoventilation, airway spasm, bradycardia, tachycardia In addition, we aimed to investigate the incidence of anesthesia complications in RT patients and possible related factors with complications.
- Conditions
- Pediatric Sedation, Radiotherapy, Inhalation Anesthesia
- Being tested
- Sedation with sevoflurane insufflation, intravenous sedation
- Keywords
- insufflation sedation, intravenous sedation, radiotherapy anesthesia, pediatric sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation with sevoflurane insufflationProcedure or surgery
Induction with %8sevoflurane after adequate sedation reducing %3
intravenous sedationProcedure or surgery
midazolam +ketamine + atropine
| Study group | Role | What they receive |
|---|---|---|
| Sedation with Insufflation | Active comparator | Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start Receives: Procedure: Sedation with sevoflurane insufflation |
| İntravenous sedation | Active comparator | Midazolam+ Ketamine sedation Receives: Procedure: intravenous sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of the successful radiotherapy sessions
succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption
Measured: during radiotherapy session
number of interruptions
number of interruptions related to inadequate sedation and patient's movement in radiotherapy session
Measured: during radiotherapy session
PSSS
5:Patient is moving 4: gentle immobilization for positioning. 3: do not require restraint to stop movement during the procedure. 2: Quiet (asleep or awake), not moving during procedure
1: Deeply asleep with normal vital signs, but requiring airway intervention 0: Sedation associated with abnormal physiologic parameters that require acute intervention
Measured: during radiotherapy session
Secondary outcomes (2)
sPO2
peripheral oxygen saturation
Measured: during radiotherapy session
HR
Heart Rate
Measured: during radiotherapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start5 Jul 2020
- Primary completion20 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric SedationStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismail aytaç, Ankara City Hospital Bilkent
- Investigators
- İsmail Aytac, Principal investigator, Ankara City Hospital Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483258
- Sponsor's protocol ID
- E1-20-884
- Status last verified
- Jul 2020
- First submitted
- 18 Jul 2020
- Last updated
- 23 Jul 2020
- 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 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over Analysis of Sevoflurane Insufflation and Intravenous Sedation for Radiotherapy in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04483258
- Acronym / sponsor ID
- E1-20-884
- Conditions
- Pediatric Sedation, Radiotherapy, Inhalation Anesthesia
- Keywords
- insufflation sedation, intravenous sedation, radiotherapy anesthesia, pediatric sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 5 Jul 2020 (actual)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 23 Jul 2020 (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.
aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy patients
Detailed description
aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy(RT) patients in terms of success of the procedure (continuous completion of the RT session by providing inactivity) and complications such as desaturation, hypoventilation, airway spasm, bradycardia, tachycardia In addition, we aimed to investigate the incidence of anesthesia complications in RT patients and possible related factors with complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.
| Arm | Type | Receives |
|---|---|---|
| Sedation with Insufflation | Active comparator | Procedure: Sedation with sevoflurane insufflationSedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start |
| İntravenous sedation | Active comparator | Procedure: intravenous sedationMidazolam+ Ketamine sedation |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- undergoing radiotherapy session
Key exclusion criteria (9 listed)
- family refusal
- chronic nausea and vomiting
- apnea history, pneumonia, asthma, bronchiolitis etc. respiratory tract infection or diseases
- cardiac disease
- kidney failure
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 |
|---|---|---|
| Sedation with sevoflurane insufflationInduction with %8sevoflurane after adequate sedation reducing %3 | Procedure or surgery | Sedation with Insufflation |
| intravenous sedationmidazolam +ketamine + atropine | Procedure or surgery | İntravenous sedation |
Primary outcome
number of the successful radiotherapy sessions
Time frame: during radiotherapy session
succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption
number of interruptions
Time frame: during radiotherapy session
number of interruptions related to inadequate sedation and patient's movement in radiotherapy session
PSSS
Time frame: during radiotherapy session
5:Patient is moving 4: gentle immobilization for positioning. 3: do not require restraint to stop movement during the procedure. 2: Quiet (asleep or awake), not moving during procedure 1: Deeply asleep with normal vital signs, but requiring airway intervention 0: Sedation associated with abnormal physiologic parameters that require acute intervention
2 secondary outcomes
sPO2
Time frame: during radiotherapy session
HR
Time frame: during radiotherapy session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- 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.
İsmail Aytac principal investigator
Ankara City Hospital Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation with sevoflurane insufflation and intravenous sedation in people with Pediatric Sedation and Radiotherapy, run by Ankara City Hospital Bilkent 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 1 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: status not confirmed, as of the sponsor's last update on 23 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İsmail Aytac (05056340369, aytacismail1972@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of the successful radiotherapy sessions (time frame: during radiotherapy session). 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 23 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.