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

as an adjuvant to sevoflurane anaesthesia in children undergoing interventional or diagnostic cardiac catheterization: a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002510-23-BE

Enrollment

Registered

2014-07-16

Start date

2014-09-17

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xenon anesthesia in children undergoing cardiac catheterization

Interventions

Trade Name: Xenon Product Name: Xenon Pharmaceutical Form: Inhalation vapour INN or Proposed INN: XENON (133XE) CAS Number: 14932-42-4 Concentration unit: % percent Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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. Safety will be assessed by the incidence of intraoperative adverse events: • Heart Rate: > 20% change from baseline • Blood pressure: > 20% change from baseline • Requirements of vasopressors, inotropes and chronotropes. 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). ;Timepoint(s) of evaluation of this end point: safety parameters will be evaluated every 60 sec. from induction to awakening	—

Measure

Time frame

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. Safety will be assessed by the incidence of intraoperative adverse events: • Heart Rate: > 20% change from baseline • Blood pressure: > 20% change from baseline • Requirements of vasopressors, inotropes and chronotropes. 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). ;Timepoint(s) of evaluation of this end point: safety parameters will be evaluated every 60 sec. from induction to awakening

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Secondary

Measure	Time frame
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. -Intraoperative fluid balance. - Intraoperative xenon consumption. - Recovery times (measured from the stop of study treatment inhalation): time to open eyes, time to follow commands, 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 nausea (PON) as assessed by a visual analogue score in the post-anaesthesia care unit (PACU) and 12-24h postoperatively. - Post-operative vomiting (POV) as assessed by a visual analogue score in the post-anaesthesia care unit (PACU) and 12-24h postoperatively. - Any other complication occurring in the early postoperative period. - Duration of postanaesthesia care unit and hospital stay. - Neuro-cognitive testing, 1-2h and 12-24h postoperatively. - Longitudinal follow-up of cognitive function after 1 year. Incidence of (serious) adverse events (S)AE at any time point. ;Timepoint(s) of evaluation of this end point: Patients will be tested 1-2h, 2-24h post-procedure and 1year after the procedure	—

Measure

Time frame

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. -Intraoperative fluid balance. - Intraoperative xenon consumption. - Recovery times (measured from the stop of study treatment inhalation): time to open eyes, time to follow commands, 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 nausea (PON) as assessed by a visual analogue score in the post-anaesthesia care unit (PACU) and 12-24h postoperatively. - Post-operative vomiting (POV) as assessed by a visual analogue score in the post-anaesthesia care unit (PACU) and 12-24h postoperatively. - Any other complication occurring in the early postoperative period. - Duration of postanaesthesia care unit and hospital stay. - Neuro-cognitive testing, 1-2h and 12-24h postoperatively. - Longitudinal follow-up of cognitive function after 1 year. Incidence of (serious) adverse events (S)AE at any time point. ;Timepoint(s) of evaluation of this end point: Patients will be tested 1-2h, 2-24h post-procedure and 1year after the procedure

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Countries

Belgium

Contacts

Public ContactAnesthesia research

University hospitals Leuven

christel.huygens@uzleuven.be0032 16344620

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 5, 2026