EUCTR2014-002510-23-BE
Active, not recruiting
Phase 1
as an adjuvant to sevoflurane anaesthesia in children undergoing interventional or diagnostic cardiac catheterization: a randomized controlled clinical trial
niversity hospitals of Leuven0 sites40 target enrollmentJuly 16, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Xenon anesthesia in children undergoing cardiac catheterization
- Sponsor
- niversity hospitals of Leuven
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children aged 4\-12 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: 40
- •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 pediatric cardiologist)
- •Psychomotoric retardation (defined as the non\-achievement of age\-specific developmental milestones)
- •Lack of informed consent
Outcomes
Primary Outcomes
Not specified
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