search
Back to results

Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

Primary Purpose

Pediatric Sedation, Radiotherapy, Inhalation Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sedation with sevoflurane insufflation
intravenous sedation
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pediatric Sedation focused on measuring insufflation sedation, intravenous sedation, radiotherapy anesthesia, pediatric sedation

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ankara City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sedation with Insufflation

İntravenous sedation

Arm Description

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

Midazolam+ Ketamine sedation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

sPO2
peripheral oxygen saturation
HR
Heart Rate

Full Information

First Posted
July 18, 2020
Last Updated
July 22, 2020
Sponsor
Ankara City Hospital Bilkent
search

1. Study Identification

Unique Protocol Identification Number
NCT04483258
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Sedation, Radiotherapy, Inhalation Anesthesia
Keywords
insufflation sedation, intravenous sedation, radiotherapy anesthesia, pediatric sedation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sedation with Insufflation
Arm Type
Active Comparator
Arm Description
Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start
Arm Title
İntravenous sedation
Arm Type
Active Comparator
Arm Description
Midazolam+ Ketamine sedation
Intervention Type
Procedure
Intervention Name(s)
Sedation with sevoflurane insufflation
Intervention Description
Induction with %8sevoflurane after adequate sedation reducing %3
Intervention Type
Procedure
Intervention Name(s)
intravenous sedation
Intervention Description
midazolam +ketamine + atropine
Primary Outcome Measure Information:
Title
number of the successful radiotherapy sessions
Description
succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption
Time Frame
during radiotherapy session
Title
number of interruptions
Description
number of interruptions related to inadequate sedation and patient's movement in radiotherapy session
Time Frame
during radiotherapy session
Title
PSSS
Description
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
Time Frame
during radiotherapy session
Secondary Outcome Measure Information:
Title
sPO2
Description
peripheral oxygen saturation
Time Frame
during radiotherapy session
Title
HR
Description
Heart Rate
Time Frame
during radiotherapy session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
İsmail Aytac
Phone
05056340369
Email
aytacismail1972@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İsmail Aytac
Organizational Affiliation
Ankara City Hospital Anesthesiology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
İsmail Aytac
Phone
+905056340369
Email
aytacismail1972@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

We'll reach out to this number within 24 hrs