Xenon for the prevention of postoperative delirium in cardiac surgery: Aprosptective randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005370-11-BE

Enrollment

172

Registered

2015-05-13

Start date

2015-05-04

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

Xenon anesthesia in cardiac surgery

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age > 65years - patient scheduled for elective heart surgery with the use of cardiopulmonary bypass - dutch proficiency Are the trial subjects under 18? no Number of subjects for this age range: 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) yes F.1.3.1 Number of subjects for this age range 190

Exclusion criteria

Exclusion criteria: intraoperative need for an increased fraction of inspired oxygen - Chronic obstructive lung disease (GOLD >II) - Critical preoperative state - Disabling neuropsychatric disorders - history of alcohol/drug abuse - increased intracranial pressure - presence of delirium at screening

Design outcomes

Primary

Measure	Time frame
Main Objective: Incidence of postoperative delirium (POD) as assessed by the CAM;Secondary Objective: - Duration & severity of POD - Incidence of MACCE (major adverse cardiac & cerebral events) - Other cerebrovascular accidents not included in the MACCE - Postoperative renal function - Requirement for blood transfusion - duration of ICU & hospital stay - incidence of (serious) adverse events - intraoperative hemodynamic & respiratory profile - introperative use of inotropi/vasoactive medication;Primary end point(s): We hypothesize that in older cardiac surgical patients, the use of xenon-anesthesia reduces the incidence of Postoeprative delirum when compared to the conventionally used anesthetic sevoflurane.;Timepoint(s) of evaluation of this end point: daily until discharge of the patient	—

Measure

Time frame

Main Objective: Incidence of postoperative delirium (POD) as assessed by the CAM;Secondary Objective: - Duration & severity of POD - Incidence of MACCE (major adverse cardiac & cerebral events) - Other cerebrovascular accidents not included in the MACCE - Postoperative renal function - Requirement for blood transfusion - duration of ICU & hospital stay - incidence of (serious) adverse events - intraoperative hemodynamic & respiratory profile - introperative use of inotropi/vasoactive medication;Primary end point(s): We hypothesize that in older cardiac surgical patients, the use of xenon-anesthesia reduces the incidence of Postoeprative delirum when compared to the conventionally used anesthetic sevoflurane.;Timepoint(s) of evaluation of this end point: daily until discharge of the patient

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Secondary

Measure	Time frame
Secondary end point(s): duration of postoperative delirium Incidence of major cardic and cerebral adverse events postoperative renal function duration of ICU and hospital stay intraoperative use of inotropic/vasoactive medication requirement for bloodtransfusion severity of postoperative critical illness (APACHE and SOFA score) intraoperative hemodynamic and respiratory profile;Timepoint(s) of evaluation of this end point: daily until discharge of the patient 6 months after surgery	—

Measure

Time frame

Secondary end point(s): duration of postoperative delirium Incidence of major cardic and cerebral adverse events postoperative renal function duration of ICU and hospital stay intraoperative use of inotropic/vasoactive medication requirement for bloodtransfusion severity of postoperative critical illness (APACHE and SOFA score) intraoperative hemodynamic and respiratory profile;Timepoint(s) of evaluation of this end point: daily until discharge of the patient 6 months after surgery

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Countries

Belgium

Contacts

Public ContactResearch Anesthesiology

University Hospitals Leuven

christel.hugyens@uzleuven.be+3216344270

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 28, 2026