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Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04483258
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Information provided by (Responsible Party):
ismail aytaç, 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

Condition or disease Intervention/treatment Phase
Pediatric Sedation Radiotherapy Inhalation Anesthesia Procedure: Sedation with sevoflurane insufflation Procedure: intravenous sedation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Cross-over Analysis of Sevoflurane Insufflation and Intravenous Sedation for Radiotherapy in Pediatric Patients
Actual Study Start Date : July 5, 2020
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arm Intervention/treatment
Active Comparator: Sedation with Insufflation
Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start
Procedure: Sedation with sevoflurane insufflation
Induction with %8sevoflurane after adequate sedation reducing %3

Active Comparator: İntravenous sedation
Midazolam+ Ketamine sedation
Procedure: intravenous sedation
midazolam +ketamine + atropine

Primary Outcome Measures :
  1. number of the successful radiotherapy sessions [ Time Frame: during radiotherapy session ]
    succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption

  2. number of interruptions [ Time Frame: during radiotherapy session ]
    number of interruptions related to inadequate sedation and patient's movement in radiotherapy session

  3. 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

Secondary Outcome Measures :
  1. sPO2 [ Time Frame: during radiotherapy session ]
    peripheral oxygen saturation

  2. HR [ Time Frame: during radiotherapy session ]
    Heart Rate

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04483258

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Contact: İsmail Aytac 05056340369

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Ankara City Hospital Recruiting
Ankara, Turkey, 06800
Contact: İsmail Aytac    +905056340369   
Sponsors and Collaborators
Ankara City Hospital Bilkent
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Principal Investigator: İsmail Aytac Ankara City Hospital Anesthesiology Department
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Responsible Party: ismail aytaç, Principal Investigator, Ankara City Hospital Bilkent Identifier: NCT04483258    
Other Study ID Numbers: E1-20-884
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ismail aytaç, Ankara City Hospital Bilkent:
insufflation sedation
intravenous sedation
radiotherapy anesthesia
pediatric sedation
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs