| Primary | Number of Participants With Myocardial Necrosis (MN) | Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique) | Per protocol set (PPS): Randomised patients who started general anaesthesia induction and with no major protocol violations. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation. | Posted | | Number | | participants | | 3 Postoperative Days | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The percentage of patients with MN during the 3 postoperative days in the sevoflurane group and in the xenon group was expected to be 20%. The margin of non-inferiority was 10%. Thus the sample size to prove non-inferiority was 252 patients per group with α = 0.025, a power of 0.80 and the following hypotheses: H0: Px-Pc ≥ 10%; H1: Px-Pc < 10%. As it was expected that approximately 15% of patients would be non-evaluable, a total of 600 patients were included. | Difference of proportion | | 0.0052 | | Difference of proportion | 0.19 | | | 2-Sided | 95 | -6.70 | 7.07 | | | | Yes | Non-Inferiority or Equivalence | |
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| Secondary | Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories) | At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques) | Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation. | Posted | | Number | | participants | | 3 Postoperative days | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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| Secondary | Number of Participants With Myocardial Infarction (MI) | Patients with Confirmed Myocardial Infarction (MI) by the Investigators | Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation. | Posted | | Number | | participants | | 3 Postoperative Days | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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| Secondary | Number of Participants With Cerebro-Vascular Event | Patients with Cerebro-Vascular Event in the FAS | Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation. | Posted | | Number | | participants | | 3 postoperative days | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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| Secondary | Number of Participants With Life-Threatening Arrhythmia | Patients with Life-Threatening Arrhythmia in the FAS | Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation. | Posted | | Number | | participants | | 3 Postoperative Days | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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| Secondary | Number of Participants Who Died From Cardiac Origin | No patient died from a cardiac cause during the 3 postoperative days. | Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation. | Posted | | Number | | participants | | 3 postoperative days | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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| Secondary | Number of Participants With Composite Endpoint | Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin | Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation. | Posted | | Number | | participants | | 3 postoperative days | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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| Secondary | Systolic Blood Pressure (SBP) | Repeated Systolic Blood Pressure measurements during the perioperative period | Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation. | Posted | | Mean | Standard Deviation | mm Hg | | From pre-induction to recovery of anesthesia | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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| Secondary | Vital Signs (SBP and DBP Changes) | Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP) | Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received. | Posted | | Mean | Standard Deviation | mm Hg | | From pre-induction to Postoperative Day 3 | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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| Secondary | Vital Signs (Heart Rate Changes) | Changes from baseline for Heart Rate (HR) | Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received. | Posted | | Mean | Standard Deviation | beats per minute | | From pre-induction to Postoperative Day 3 | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B) |
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| Secondary | Number of Participants With Chest Pain During the 3 Postoperative Days | Patients with Chest Pain reported at least once per day during the 3 Postoperative Days | Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received. | Posted | | Number | | participants | | From Day 0 until Postoperative Day 3 | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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| Secondary | Urine Output | Urine volume in milliliter (mL) during the first postoperative hours | Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received. | Posted | | Mean | Standard Deviation | mL | | From Day 0 until Postoperative Day 1 | | | | ID | Title | Description |
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| OG000 | Xenon | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A) | | OG001 | Sevoflurane | 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B) |
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