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aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation with Insufflation | Active Comparator | Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start |
|
| İntravenous sedation | Active Comparator | Midazolam+ Ketamine sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedation with sevoflurane insufflation | Procedure | Induction with %8sevoflurane after adequate sedation reducing %3 |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| sPO2 | peripheral oxygen saturation | during radiotherapy session |
| HR | Heart Rate | during radiotherapy session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| İsmail Aytac | Contact | 05056340369 | aytacismail1972@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| İsmail Aytac | Ankara City Hospital Anesthesiology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara City Hospital | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
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Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.
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| intravenous sedation | Procedure | midazolam +ketamine + atropine |
|