xenon-dexmedetomidine Anesthesia in children undergoing cardiac catheterization
Conditions
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 0-3 years of age • Patient scheduled for elective (diagnostic or therapeutic) heart catheterization under general anesthesia 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: - Lack of parental informed consent - Cyanotic congenital heart defects possibly requiring a FiO2 of > 50% during the procedure - High-risk and complex interventional procedures (as defined by the pediatric cardiologist)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this pilot trial is to estimate the effect size for xenon-dexmedetomidine anaesthesia vs. sevoflurane anaesthesia with respect to the incidence of Emergency Delirium. We hypothesize that in children undergoing cardiac catheterization, the use of dexmedetomidine as an adjunct to xenon-anesthesia reduces the incidence of ED when compared to the conventionally used anesthetic sevoflurane. ;Secondary Objective: not applicable;Primary end point(s): We hypothesize that in children undergoing cardiac catheterization, the use of dexmedetomidine as an adjunct to xenon-anesthesia reduces the incidence of Emergency Delirium when compared to the conventionally used anesthetic sevoflurane. ;Timepoint(s) of evaluation of this end point: at 5, 10, 15, 30, 45, 60, 90 min after extubation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Intraoperative hemodynamics: Heart Rate (HR) Blood pressure (BP) Requirements of vasopressors, inotropes, chronotropes and/or fluid boluses. - Incidence and duration of cerebral desaturation, defined as a decrease in rScO2 of > 20% from baseline - Feasibility parameters: Adequate depth of anaesthesia as assessed with physiological signs (absence of movements, no rise in HR or BP of >30% from BL) and BIS-values Requirement of rescue medication (propofol) to achieve an appropriate depth of anesthesia Intra-operative respiratory profile (pulse oximetry and capnography) - Recovery parameters (measured from the stop of study treatment inhalation): Time to open eyes, time to extubation, time to Aldrete score = 9 (readiness for discharge) Recovery index: RI=(1+Aldrete score at T5)/((2•time to extubation)+time to open eyes) (12) Length of PACU stay Length of hospital stay - Safety parameters: Incidence of ED as assessed with the “Paediatric Anaesthesia Emergence Delirium Scale” (PAED-scale)(11) Post-operative vomiting (POV) Post-operative care unit (PACU) 12-24h postoperatively All other (S)AE -Other: Levels of serum protein S100ß, IL-6 and IL-10 at two time points (beginning and end of the procedure) Radiation-dose Time of procedure ;Timepoint(s) of evaluation of this end point: - continuously during the procedure, - at 5, 10, 15, 30, 45, 60, 90 min after extubation and 1h after discharge from the PACU. - morning after procedure | — |
Countries
Belgium
Contacts
Public ContactDepartment Anesthesiology-Research
University Hospitals Leuven
Outcome results
None listed