Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

Not Applicable

• Conditions: Radiotherapy; Inhalation Anesthesia; Pediatric Sedation
• Interventions: Procedure: Sedation with sevoflurane insufflation; Procedure: intravenous sedation

• Registration Number: NCT04483258
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-05
• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-22
• Last Update Submitted: 2020-07-22
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23
• Primary Completion: 2020-12-20
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sedation with Insufflation	Sedation with sevoflurane insufflation	Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start
İntravenous sedation	intravenous sedation	Midazolam+ Ketamine sedation

Primary Outcome Measures

Name	Time	Method
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
number of the successful radiotherapy sessions	during radiotherapy session	succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption

Secondary Outcome Measures

Name	Time	Method
sPO2	during radiotherapy session	peripheral oxygen saturation
HR	during radiotherapy session	Heart Rate

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey