Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients

Radiotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483258
• Other study ID #: E1-20-884
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2020
• Source: Ankara City Hospital Bilkent
• Contact: Ismail Aytac
• Phone: 05056340369
• Email: aytacismail1972[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inhalation Anesthesia
• Pediatric Sedation
• Radiotherapy
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of the successful radiotherapy sessions	succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption	during radiotherapy session
Primary	number of interruptions	number of interruptions related to inadequate sedation and patient's movement in radiotherapy session	during radiotherapy session
Primary	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	sPO2	peripheral oxygen saturation	during radiotherapy session
Secondary	HR	Heart Rate	during radiotherapy session