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Clinical Trials/EUCTR2014-002510-23-BE
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.

Registry
who.int
Start Date
July 16, 2014
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity hospitals of Leuven

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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