Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04483258

Enrollment

Registered

2020-07-23

Start date

2020-07-05

Completion date

2020-12-30

Last updated

2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Sedation, Radiotherapy, Inhalation Anesthesia

Keywords

insufflation sedation, intravenous sedation, radiotherapy anesthesia, pediatric sedation

Brief summary

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.

Interventions

PROCEDURESedation with sevoflurane insufflation

Induction with %8sevoflurane after adequate sedation reducing %3

PROCEDUREintravenous sedation

midazolam +ketamine + atropine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.

Eligibility

Sex/Gender

ALL

Age

1 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
sPO2	during radiotherapy session	peripheral oxygen saturation
HR	during radiotherapy session	Heart Rate

Countries

Turkey (Türkiye)

Contacts

Primary Contactİsmail Aytac

aytacismail1972@gmail.com05056340369

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026