Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

NCT04483258 | Unknown

• 1 other identifier: E1-20-884
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric Sedation; Radiotherapy; Inhalation Anesthesia

Keywords

insufflation sedation; intravenous sedation; radiotherapy anesthesia; pediatric sedation

Outcome Measures

Primary Outcomes (3)

• number of the successful radiotherapy sessions

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

  during radiotherapy session

• number of interruptions

  number of interruptions related to inadequate sedation and patient's movement in radiotherapy session

  during radiotherapy session

• PSSS

  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

  during radiotherapy session

Secondary Outcomes (2)

• sPO2

  during radiotherapy session

• HR

  during radiotherapy session

Study Arms (2)

Sedation with Insufflation

ACTIVE COMPARATOR

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

Procedure: Sedation with sevoflurane insufflation

İntravenous sedation

ACTIVE COMPARATOR

Midazolam+ Ketamine sedation

Procedure: intravenous sedation

Interventions

Sedation with sevoflurane insufflation PROCEDURE

Induction with %8sevoflurane after adequate sedation reducing %3

Sedation with Insufflation

intravenous sedation PROCEDURE

midazolam +ketamine + atropine

İntravenous sedation

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• undergoing radiotherapy session

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Study Officials

• İsmail Aytac

  Ankara City Hospital Anesthesiology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İsmail Aytac

CONTACT

05056340369; aytacismail1972@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: July 23, 2020
• Study Start: July 5, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 30, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)