Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

NCT ID: NCT04483258

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-05

Study Completion Date

2020-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pediatric Sedation Radiotherapy Inhalation Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sedation with Insufflation

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

Group Type ACTIVE_COMPARATOR

Sedation with sevoflurane insufflation

Intervention Type PROCEDURE

Induction with %8sevoflurane after adequate sedation reducing %3

İntravenous sedation

Midazolam+ Ketamine sedation

Group Type ACTIVE_COMPARATOR

intravenous sedation

Intervention Type PROCEDURE

midazolam +ketamine + atropine

Interventions

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Sedation with sevoflurane insufflation

Induction with %8sevoflurane after adequate sedation reducing %3

Intervention Type PROCEDURE

intravenous sedation

midazolam +ketamine + atropine

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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ismail aytaç

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İsmail Aytac

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Anesthesiology Department

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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İsmail Aytac

Role: CONTACT

05056340369

Facility Contacts

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İsmail Aytac

Role: primary

+905056340369

Other Identifiers

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E1-20-884

Identifier Type: -

Identifier Source: org_study_id

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