Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

Ankara City Hospital

Status: Unknown

Conditions: Radiotherapy; Pediatric Sedation; Inhalation Anesthesia

Treatments: Procedure: intravenous sedation; Procedure: Sedation with sevoflurane insufflation

Study type: Interventional

Funder types: Other

Identifiers

NCT04483258

E1-20-884

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sedation with Insufflation

Active Comparator group

Description:

Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start

Treatment:

Procedure: Sedation with sevoflurane insufflation

İntravenous sedation

Active Comparator group

Description:

Midazolam+ Ketamine sedation

Treatment:

Procedure: intravenous sedation