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Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT04483258
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
ismail aytaç, Ankara City Hospital Bilkent

Tracking Information
First Submitted Date  ICMJE July 18, 2020
First Posted Date  ICMJE July 23, 2020
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE July 5, 2020
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2020)
  • number of the successful radiotherapy sessions [ Time Frame: during radiotherapy session ]
    succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption
  • number of interruptions [ Time Frame: during radiotherapy session ]
    number of interruptions related to inadequate sedation and patient's movement in radiotherapy session
  • PSSS [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2020)
  • sPO2 [ Time Frame: during radiotherapy session ]
    peripheral oxygen saturation
  • HR [ Time Frame: during radiotherapy session ]
    Heart Rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients
Official Title  ICMJE Cross-over Analysis of Sevoflurane Insufflation and Intravenous Sedation for Radiotherapy in Pediatric Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pediatric Sedation
  • Radiotherapy
  • Inhalation Anesthesia
Intervention  ICMJE
  • Procedure: Sedation with sevoflurane insufflation
    Induction with %8sevoflurane after adequate sedation reducing %3
  • Procedure: intravenous sedation
    midazolam +ketamine + atropine
Study Arms  ICMJE
  • Active Comparator: Sedation with Insufflation
    Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start
    Intervention: Procedure: Sedation with sevoflurane insufflation
  • Active Comparator: İntravenous sedation
    Midazolam+ Ketamine sedation
    Intervention: Procedure: intravenous sedation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: İsmail Aytac 05056340369 aytacismail1972@gmail.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04483258
Other Study ID Numbers  ICMJE E1-20-884
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ismail aytaç, Ankara City Hospital Bilkent
Study Sponsor  ICMJE Ankara City Hospital Bilkent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: İsmail Aytac Ankara City Hospital Anesthesiology Department
PRS Account Ankara City Hospital Bilkent
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP