Xenon anesthesia in children undergoing cardiac catherization MedDRA version: 18.0 Level: LLT Classification code 10018061 Term: General anesthesia System Organ Class: 100000004865
Conditions
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Hemodynamic stability during the procedure. Hemodynamic stability will be defined as the absence of the following events: • Heart Rate: > 20% change from baseline (and obviously not caused by operative manipulation with the cardiac catheter) • Blood pressure: > 20% change from baseline • Requirements of vasopressors, inotropes, chronotropes and/or fluid boluses. ;Main Objective: We hypothesise that the administration of 50-65 % xenon as an adjuvant to general anaesthesia with sevoflurane results in superior hemodynamic stability when compared to sevoflurane anesthesia alone. ;Secondary Objective: • Invasive haemodynamic data, • determination of S100? and IL-6. • Intraoperative fluid balance. • Intraoperative xenon consumption. • Feasibility will be tested by intraoperative monitoring of depth of anaesthesia (physiological signs and BIS) and by the intraoperative respiratory profile (as continuously measured by pulse oximetry and capnography). • Recovery times (measured from the stop of study treatment inhalation): time to open eyes, time to extubation, time to Aldrete score = 9. • Incidence of emergence delirium as assessed with the “Paediatric Anaesthesia Emergence Delirium Scale” and the “Four-point Agitation Scale” • Post-operative vomiting (POV) in the post-anaesthesia care unit (PACU) and 12-24h postoperatively. • Any other complication occurring in the early postoperative period. • Duration of PACU and hospital stay. ;Timepoint(s) of evaluation of this end point: Intraoperative data are recorded manually in 5min intervals on specific case record forms (CRF). BIS-values will be electronically recorded every second. In addition, important pre- and postoperative data will be manually documented during pre-specified visits on CRF’s | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Intraoperative data are recorded manually in 5min intervals on specific case record forms (CRF). BIS-values will be electronically recorded every second; post procedural patient will be evaluated at 5, 10, 15, 30, 45, 60, 90 and the morning following the procedure;Secondary end point(s): • Invasive haemodynamic data, including intra-cardiac, systemic and pulmonary vascular pressures that are routinely measured during these procedures by the interventional cardiologist, after induction of anaesthesia and at the end of the procedure. • At the same time points, small blood samples will be obtained from the catheter (in situ for the interventional procedure). After centrifugation this blood will be stored at -80°C for later determination of S100? and IL-6. • Intraoperative fluid balance. • Intraoperative xenon consumption. • Feasibility will be tested by intraoperative monitoring of depth of anaesthesia (physiological signs and BIS) and by the intraoperative respiratory profile (as continuously measured by pulse oximetry and capnography). • Recovery times (measured from the stop of study treatment inhalation): time to open eyes, time to extubation, time to Aldrete score = 9.{Aldrete:1995vb} | — |
Countries
Belgium
Contacts
Public ContactAnesthesia Research
University Hospitals Leuven
Outcome results
None listed