E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Xenon anesthesia in children undergoing cardiac catherization |
Xenon anesthesie bij kinderen die een hartkatheterisatie moeten ondergaan |
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E.1.1.1 | Medical condition in easily understood language |
Xenon anesthesia in children undergoing cardiac catherization |
Xenon anesthesie bij kinderen die een hartkatheterisatie moeten ondergaan |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018061 |
E.1.2 | Term | General anesthesia |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
• Invasive haemodynamic data,
• determination of S100Β 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Children aged 0-3 years scheduled for elective diagnostic or interventional cardiac catheterization under general anaesthesia |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | 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 |
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E.5.2 | 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 S100Β 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}
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |