Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

Ketamine

Brief Summary

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

Intervention / Treatment

Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.
  • Sedation with sevoflurane insufflation (PROCEDURE)
    Induction with %8sevoflurane after adequate sedation reducing %3
  • intravenous sedation (PROCEDURE)
    midazolam +ketamine + atropine

Condition or Disease

  • Pediatric Sedation
  • Radiotherapy
  • Inhalation Anesthesia

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 1 Year to 12 Years
    Enrollment: 20 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    Clinical Trial Dates

    Start date: Jul 05, 2020 ACTUAL
    Primary Completion: Dec 20, 2020 ESTIMATED
    Completion Date: Dec 30, 2020 ESTIMATED
    Study First Posted: Jul 23, 2020 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 22, 2020

    Sponsors / Collaborators

    Lead Sponsor: Ankara City Hospital Bilkent
    Responsible Party: N/A

    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.

    Participant Groups

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

    • Midazolam+ Ketamine sedation

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption

    • number of interruptions related to inadequate sedation and patient's movement in 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 Outcomes

    • peripheral oxygen saturation

    • Heart Rate

    More Details

    NCT Number: NCT04483258
    Other IDs: E1-20-884
    Study URL: https://clinicaltrials.gov/study/NCT04483258
    Last updated: Sep 29, 2023