Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

Study Overview
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Brief Summary
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aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy patients

Detailed Description
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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.

Official Title
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Cross-over Analysis of Sevoflurane Insufflation and Intravenous Sedation for Radiotherapy in Pediatric Patients

Conditions
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Pediatric Sedation, Radiotherapy, Inhalation Anesthesia

Intervention / Treatment
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* Procedure: Sedation with sevoflurane insufflation
* Procedure: intravenous sedation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing radiotherapy session Exclusion Criteria: family refusal chronic nausea and vomiting apnea history, pneumonia, asthma, bronchiolitis etc. respiratory tract infection or diseases cardiac disease kidney failure liver failure anticipated difficult airway metabolic diseases neurological or muscular diseases.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sedation with Insufflation<br>Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start | Procedure: Sedation with sevoflurane insufflation<br>* Induction with %8sevoflurane after adequate sedation reducing %3<br>|
| Active Comparator: İntravenous sedation<br>Midazolam+ Ketamine sedation | Procedure: intravenous sedation<br>* midazolam +ketamine + atropine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of the successful radiotherapy sessions | succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption | during radiotherapy session | 
| number of interruptions | number of interruptions related to inadequate sedation and patient's movement in radiotherapy session | 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 | during radiotherapy session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sPO2 | peripheral oxygen saturation | during radiotherapy session | 
| HR | Heart Rate | during radiotherapy session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insufflation sedation, intravenous sedation, radiotherapy anesthesia, pediatric sedation