Xenon anesthesie in combinatie met sevoflurane anesthesie bij kinderen jonger dan 4 jaar die een hartkatheterisatie ondergaa

Phase 1

• Conditions: Xenon anesthesia in children undergoing cardiac catherization; MedDRA version: 18.0Level: LLTClassification code 10018061Term: General anesthesiaSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-002329-20-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-08
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Children aged 0-3 years scheduled for elective diagnostic or interventional cardiac catheterization under general anaesthesia
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Cyanotic congenital heart defects possibly requiring a FiO2 of > 40% during the procedure
•High-risk and complex interventional procedures (as defined by the paediatric cardiologist)
•Lack of parental informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified