Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

July 22, 2020 updated by: ismail aytaç, Ankara City Hospital Bilkent

Cross-over Analysis of Sevoflurane Insufflation and Intravenous Sedation for Radiotherapy in Pediatric Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of the successful radiotherapy sessions
Time Frame: during radiotherapy session
succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption
during radiotherapy session
number of interruptions
Time Frame: during radiotherapy session
number of interruptions related to inadequate sedation and patient's movement in radiotherapy session
during 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
during radiotherapy session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sPO2
Time Frame: during radiotherapy session
peripheral oxygen saturation
during radiotherapy session
HR
Time Frame: during radiotherapy session
Heart Rate
during radiotherapy session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2020

Primary Completion (Anticipated)

December 20, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

July 18, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1-20-884

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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