General Anesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia.
Condition: Anaesthesia
MeSH terms: Respiratory Aspiration
Intervention: Xenon; Xenon; Medical Air in Oxygen
Intervention description: Maintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia.; Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia.; Maintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia.
Intervention MeSH terms: Xenon
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 102.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Xenon in Anaesthesia

Summary:

      The purpose of this study is to evaluate the quantity of propofol administered with Xenon in
      two inspiratory concentrations, to maintain comparable depth of anaesthesia during the
      maintenance period of general anaesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient ≥ 50 years old

          -  ASA (American Society of Anaesthesiologists) Physical Status III

          -  Patient with increased risk of perioperative cardiac complications (Revised Cardiac
             Risk Index>=2)

          -  Surgical operation: laparotomy or orthopaedic surgery or laparoscopy

          -  Planned duration of general anaesthesia in the range of 2-6 hours

          -  Patient willing and able to complete the requirements of this study including the
             signature of the written informed consent

        Exclusion Criteria:

          -  Patient with severe impairment of cardiac function (Left Ventricular Ejection Fraction
             < 35%)

          -  Patient with drug-eluting stent placed within 12 months prior to selection

          -  Woman of child-bearing potential not implementing adequate contraceptive methods

          -  Pregnant or lactating woman

          -  Surgical procedure in emergency

          -  Chronic opioids pain therapy

          -  Serious illness or medical conditions which are possible contra indication for
             elective general anaesthesia or administration of intra operative treatments, or which
             are interfering with the monitoring devices, such as:

               -  Myocardial infarction within 6 months prior to selection

               -  Any significant history of allergy/hypersensitivity to any drugs used during the
                  study, to silicone or to latex

               -  Severely impaired hearing

               -  Known severe neurological disorders

               -  Any medical condition which does not justify the trial participation in the
                  investigator's judgement

               -  General anaesthesia within 7 days prior to selection

               -  Laparotomy within 3 months prior to selection, only for patients undergoing
                  laparotomy

          -  History of drug abuse or psychiatric disorders which would impair the understanding of
             the necessary information or render medically or legally not able to give written
             informed consent

          -  Concurrent treatment with any other experimental drugs

          -  Participation in any other clinical trial within 4 weeks prior to selection