Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

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

Tracking Information

• First Submitted Date: July 18, 2020
• First Posted Date: July 23, 2020
• Last Update Posted Date: July 23, 2020
• Actual Study Start Date: July 5, 2020
• Estimated Primary Completion Date: December 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Pediatric Sedation
• Radiotherapy
• Inhalation Anesthesia

Intervention

• Procedure: Sedation with sevoflurane insufflation
  Induction with %8sevoflurane after adequate sedation reducing %3
• Procedure: intravenous sedation
  midazolam +ketamine + atropine

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 22, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2020
• Estimated Primary Completion Date: December 20, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 1 Year to 12 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: İsmail Aytac; 05056340369; aytacismail1972@gmail.com

• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04483258
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: ismail aytaç, Ankara City Hospital Bilkent
• Original Responsible Party: Same as current
• Current Study Sponsor: Ankara City Hospital Bilkent
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: İsmail Aytac; Ankara City Hospital Anesthesiology Department

• PRS Account: Ankara City Hospital Bilkent
• Verification Date: July 2020