Safety and feasibility of xenon as an adjuvant to sevoflurane anesthesia, to children who are undergoing an interventional or diagnostic cardiac catheterization: a randomized controlled clinical trial

Phase 1

Conditions: Xenon anesthesia in children undergoing cardiac catheterization
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-002510-23-BE

Lead Sponsor: niversity hospitals of Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: As a primary study aim we hypothesize that the administration of 50% Xenon as an adjuvant to general anesthesia with sevoflurane is safe and feasible;Secondary Objective: evaluation of haemodynamic parameters and the analysis of postoperative neurocognitive function.;Primary end point(s): Feasibility and safety criteria of xenon anaesthesia in children.<br>Safety will be assessed by the incidence of intraoperative adverse events:<br><br>•Heart Rate: > 20% change from baseline<br>•Blood pressure: > 20% change from baseline<br>•Requirements of vasopressors, inotropes and chronotropes.<br> <br>Feasibility will be tested by intraoperative monitoring of depth of anaesthesia (BIS) and by the intraoperative respiratory profile (as continuously measured by pulse oximetry and capnography).<br>;Timepoint(s) of evaluation of this end point: safety parameters will be evaluated every 60 sec. from induction to awakening

Secondary Outcome Measures