Trial Outcomes & Findings for General Anesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia. (NCT NCT00919126)

NCT ID: NCT00919126

Last Updated: 2014-09-25

Results Overview

Dose of propofol administered with a Target Controlled Infusion (TCI) device, cerebral concentration equal to 5 µg/mL at the end of induction, and then concentration adjusted to the level of depth of anaesthesia during maintenance. Depth of anaesthesia continuously assessed by signals derived from electroencephalographic recording. Analgesia during induction and maintenance obtained with remifentanil administered with a second TCI device at the stable cerebral concentration of 7 ng/mL.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

102 participants

Primary outcome timeframe

Maintenance period (1 Day)

Results posted on

2014-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Group A Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B Xenon 70% (65%-75%) in Oxygen (25%-35%)	Group C Medical Air in Oxygen (45%-55%)
Overall Study STARTED	32	37	33
Overall Study COMPLETED	31	32	32
Overall Study NOT COMPLETED	1	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

General Anesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=32 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=37 Participants Xenon 70% (65%-75%) in Oxygen (25%-35%)	Group C n=33 Participants Medical Air in Oxygen (45%-55%)	Total n=102 Participants Total of all reporting groups
Age, Continuous	69.8 years STANDARD_DEVIATION 8.2 • n=5 Participants	70.0 years STANDARD_DEVIATION 9.7 • n=7 Participants	71.1 years STANDARD_DEVIATION 6.9 • n=5 Participants	70.3 years STANDARD_DEVIATION 8.3 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	25 Participants n=7 Participants	21 Participants n=5 Participants	68 Participants n=4 Participants
Weight	81.18 kg STANDARD_DEVIATION 17.39 • n=5 Participants	80.41 kg STANDARD_DEVIATION 19.61 • n=7 Participants	81.12 kg STANDARD_DEVIATION 16.74 • n=5 Participants	80.88 kg STANDARD_DEVIATION 17.85 • n=4 Participants
Height	168.4 cm STANDARD_DEVIATION 8.8 • n=5 Participants	168.0 cm STANDARD_DEVIATION 8.9 • n=7 Participants	169.2 cm STANDARD_DEVIATION 9.8 • n=5 Participants	168.5 cm STANDARD_DEVIATION 9.1 • n=4 Participants
Body Surface Area	1.938 m2 STANDARD_DEVIATION 0.228 • n=5 Participants	1.926 m2 STANDARD_DEVIATION 0.251 • n=7 Participants	1.943 m2 STANDARD_DEVIATION 0.228 • n=5 Participants	1.935 m2 STANDARD_DEVIATION 0.235 • n=4 Participants
Body Mass Index	28.71 Kg/m2 STANDARD_DEVIATION 6.26 • n=5 Participants	28.43 Kg/m2 STANDARD_DEVIATION 6.09 • n=7 Participants	28.39 Kg/m2 STANDARD_DEVIATION 5.98 • n=5 Participants	28.51 Kg/m2 STANDARD_DEVIATION 6.05 • n=4 Participants
Planned High-Risk Surgical Procedures No	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	12 participants n=4 Participants
Planned High-Risk Surgical Procedures Yes	28 participants n=5 Participants	33 participants n=7 Participants	29 participants n=5 Participants	90 participants n=4 Participants
History of Ischemic Heart Disease No	9 participants n=5 Participants	14 participants n=7 Participants	11 participants n=5 Participants	34 participants n=4 Participants
History of Ischemic Heart Disease Yes	23 participants n=5 Participants	23 participants n=7 Participants	22 participants n=5 Participants	68 participants n=4 Participants
History of Congestive Heart Failure No	23 participants n=5 Participants	28 participants n=7 Participants	22 participants n=5 Participants	73 participants n=4 Participants
History of Congestive Heart Failure Yes	9 participants n=5 Participants	9 participants n=7 Participants	11 participants n=5 Participants	29 participants n=4 Participants
History of Cerebrovascular Disease No	27 participants n=5 Participants	27 participants n=7 Participants	21 participants n=5 Participants	75 participants n=4 Participants
History of Cerebrovascular Disease Yes	5 participants n=5 Participants	10 participants n=7 Participants	12 participants n=5 Participants	27 participants n=4 Participants
Pre-Operative Treatment With Insulin or Antidiabetics No	20 participants n=5 Participants	24 participants n=7 Participants	25 participants n=5 Participants	69 participants n=4 Participants
Pre-Operative Treatment With Insulin or Antidiabetics Yes	12 participants n=5 Participants	13 participants n=7 Participants	8 participants n=5 Participants	33 participants n=4 Participants
Pre-Operative Serum Creatinine >2.0 mg/dL No	29 participants n=5 Participants	33 participants n=7 Participants	28 participants n=5 Participants	90 participants n=4 Participants
Pre-Operative Serum Creatinine >2.0 mg/dL Yes	3 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	12 participants n=4 Participants

PRIMARY outcome

Timeframe: Maintenance period (1 Day)

Population: The main analysis was done in the ITT Data Set (Randomised Patients).

Outcome measures

Outcome measures
Measure	Group A n=29 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=33 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=30 Participants Medical Air in Oxygen (45%-55%)
Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min)	1.683 mg adjusted Standard Deviation 0.834	1.005 mg adjusted Standard Deviation 1.121	3.987 mg adjusted Standard Deviation 1.431

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients).

Time interval between the end of maintenance period and time of tracheal tube removal.

Outcome measures

Outcome measures
Measure	Group A n=32 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=35 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=32 Participants Medical Air in Oxygen (45%-55%)
Anaesthesia Recovery Time	9.3 minutes Standard Deviation 15.8	22.2 minutes Standard Deviation 62.6	43.3 minutes Standard Deviation 180.6

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients).

Time interval between the end of maintenance period and time of Aldrete score ≥ 9.

Outcome measures

Outcome measures
Measure	Group A n=26 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=27 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=27 Participants Medical Air in Oxygen (45%-55%)
Awakening Time	53.9 minutes Standard Deviation 37.6	70.7 minutes Standard Deviation 74.2	62.6 minutes Standard Deviation 34.3

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients).

Time interval between admission in the operating room and discharge from the operating room.

Outcome measures

Outcome measures
Measure	Group A n=32 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=37 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=33 Participants Medical Air in Oxygen (45%-55%)
Stay in the Operating Room	273.1 minutes Standard Deviation 115.5	288.2 minutes Standard Deviation 119.1	315.0 minutes Standard Deviation 141.5

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients).

Time interval between admission in the recovery room and discharge from the recovery room.

Outcome measures

Outcome measures
Measure	Group A n=28 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=34 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=29 Participants Medical Air in Oxygen (45%-55%)
Stay in the Recovery Room	187.5 minutes Standard Deviation 156.3	180.7 minutes Standard Deviation 132.0	218.0 minutes Standard Deviation 243.7

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients).

Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.

Outcome measures

Outcome measures
Measure	Group A n=28 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=32 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=28 Participants Medical Air in Oxygen (45%-55%)
Haematology - Leucocytes (Giga/L) Before Anaesthesia	8.118 Giga/L Standard Deviation 2.289	8.301 Giga/L Standard Deviation 2.980	7.432 Giga/L Standard Deviation 1.641
Haematology - Leucocytes (Giga/L) Morning Following Surgery	11.429 Giga/L Standard Deviation 2.737	11.574 Giga/L Standard Deviation 4.438	11.280 Giga/L Standard Deviation 2.818

SECONDARY outcome

Timeframe: 1 Postoperative Day.

Population: The analysis was done in the ITT Data Set (Randomised Patients).

Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.

Outcome measures

Outcome measures
Measure	Group A n=28 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=32 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=28 Participants Medical Air in Oxygen (45%-55%)
Haematology - Erythrocytes (Tera/L) Before Anaesthesia	4.373 Tera/L Standard Deviation 0.553	4.219 Tera/L Standard Deviation 0.798	4.135 Tera/L Standard Deviation 0.450
Haematology - Erythrocytes (Tera/L) Morning Following Surgery	3.690 Tera/L Standard Deviation 0.529	3.763 Tera/L Standard Deviation 0.524	3.675 Tera/L Standard Deviation 0.564

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients).

Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery

Outcome measures

Outcome measures
Measure	Group A n=28 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=32 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=28 Participants Medical Air in Oxygen (45%-55%)
Haematology - Platelets (Giga/L) Before Anaesthesia	225.036 Giga/L Standard Deviation 89.556	244.656 Giga/L Standard Deviation 71.724	244.214 Giga/L Standard Deviation 80.484
Haematology - Platelets (Giga/L) Morning Following Surgery	188.036 Giga/L Standard Deviation 79.083	212.594 Giga/L Standard Deviation 79.424	196.250 Giga/L Standard Deviation 86.871

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients).

AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.

Outcome measures

Outcome measures
Measure	Group A n=24 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=28 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=26 Participants Medical Air in Oxygen (45%-55%)
Serum Chemistry - AST (GOT) (IU/L) Before Anaesthesia	28.641 IU/L Standard Deviation 32.661	31.926 IU/L Standard Deviation 25.495	30.544 IU/L Standard Deviation 27.369
Serum Chemistry - AST (GOT) (IU/L) Morning Following Surgery	44.723 IU/L Standard Deviation 66.482	139.163 IU/L Standard Deviation 420.704	62.348 IU/L Standard Deviation 65.231

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients).

ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery

Outcome measures

Outcome measures
Measure	Group A n=23 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=28 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=28 Participants Medical Air in Oxygen (45%-55%)
Serum Chemistry - ALT (GPT) (IU/L) Before Anaesthesia	28.498 IU/L Standard Deviation 31.981	24.400 IU/L Standard Deviation 13.176	28.655 IU/L Standard Deviation 27.587
Serum Chemistry - ALT (GPT) (IU/L) Morning Following Surgery	50.634 IU/L Standard Deviation 111.748	81.747 IU/L Standard Deviation 197.209	48.115 IU/L Standard Deviation 57.414

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients)

Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery

Outcome measures

Outcome measures
Measure	Group A n=23 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=27 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=26 Participants Medical Air in Oxygen (45%-55%)
Serum Chemistry - Gamma GT (IU/L) Before Anaesthesia	122.689 IU/L Standard Deviation 335.374	77.012 IU/L Standard Deviation 80.051	136.785 IU/L Standard Deviation 370.826
Serum Chemistry - Gamma GT (IU/L) Morning Following Surgery	106.234 IU/L Standard Deviation 198.074	73.021 IU/L Standard Deviation 86.695	90.345 IU/L Standard Deviation 189.828

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients).

Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery

Outcome measures

Outcome measures
Measure	Group A n=28 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=32 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=28 Participants Medical Air in Oxygen (45%-55%)
Serum Chemistry - Creatinine (Mcmol/L) Before Anaesthesia	94.625 mcmol/L Standard Deviation 66.513	106.825 mcmol/L Standard Deviation 68.814	98.830 mcmol/L Standard Deviation 40.639
Serum Chemistry - Creatinine (Mcmol/L) Morning Following Surgery	115.007 mcmol/L Standard Deviation 144.682	102.071 mcmol/L Standard Deviation 61.185	96.273 mcmol/L Standard Deviation 38.996

SECONDARY outcome

Timeframe: 1 Postoperative Day

Population: The analysis was done in the ITT Data Set (Randomised Patients).

Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery

Outcome measures

Outcome measures
Measure	Group A n=24 Participants Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=27 Participants Xenon 70%(65%-75%) in Oxygen (25%-35%)	Group C n=22 Participants Medical Air in Oxygen (45%-55%)
Serum Chemistry - Urea (mmol/L) Morning Following Surgery	7.317 mmol/L Standard Deviation 5.458	7.964 mmol/L Standard Deviation 4.404	7.609 mmol/L Standard Deviation 2.876
Serum Chemistry - Urea (mmol/L) Before Anaesthesia	7.453 mmol/L Standard Deviation 4.623	8.680 mmol/L Standard Deviation 5.882	7.886 mmol/L Standard Deviation 3.087

Adverse Events

Group A

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

Group B

Serious events: 7 serious events

Other events: 30 other events

Deaths: 0 deaths

Group C

Serious events: 5 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Prof. Dr. Med Berthold BEIN

University Hospital Schleswig-Holstein

Phone: +49(0)431-5973 739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Group A n=32 participants at risk Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=37 participants at risk Xenon 70% (65%-75%) in Oxygen (25%-35%)	Group C n=33 participants at risk Medical Air in Oxygen (45%-55%)
Infections and infestations Abdominal Sepsis	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Infections and infestations Bacteraemia	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Infections and infestations Necrotising Fasciitis	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Infections and infestations Sepsis	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Infections and infestations Septic Shock	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	3.0% 1/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Wound Decomposition	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Anastomotic Leak	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Wound Dehiscence	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Abdominal Wound Dehiscence	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	3.0% 1/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Investigations Oxygen Saturation Decreased	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Investigations PO2 Decreased	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Cardiac disorders Acute Myocardial Infarction	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Cardiac disorders Cardiac Failure Congestive	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	3.0% 1/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
General disorders Death	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
General disorders Multi-organ Failure	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Psychiatric disorders Confusional State	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Renal and urinary disorders Renal Failure	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Vascular disorders Haemorrhage	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Gastrointestinal disorders Gastrointestinal Necrosis	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	3.0% 1/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Gastrointestinal disorders Megacolon	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	3.0% 1/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Hepatobiliary disorders Hepatobiliary Disorders	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	3.0% 1/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	3.0% 1/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).

Measure	Group A n=32 participants at risk Xenon 50% (45%-55%) in Oxygen (45%-55%)	Group B n=37 participants at risk Xenon 70% (65%-75%) in Oxygen (25%-35%)	Group C n=33 participants at risk Medical Air in Oxygen (45%-55%)
Vascular disorders Hypotension	68.8% 22/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	54.1% 20/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	60.6% 20/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Vascular disorders Hypertension	28.1% 9/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	18.9% 7/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	27.3% 9/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Gastrointestinal disorders Nausea	21.9% 7/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	24.3% 9/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	15.2% 5/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Gastrointestinal disorders Vomiting	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	10.8% 4/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	9.1% 3/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Gastrointestinal disorders Constipation	9.4% 3/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	5.4% 2/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	12.1% 4/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Procedural Hypotension	9.4% 3/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	18.9% 7/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	12.1% 4/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Procedural Pain	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	13.5% 5/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	9.1% 3/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Anaesthetic Complication Cardiac	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	8.1% 3/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Post Procedural Complication	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	5.4% 2/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	3.0% 1/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Procedural Nausea	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	5.4% 2/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	6.1% 2/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Injury, poisoning and procedural complications Anaemia Postoperative	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	6.1% 2/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Investigations Myoglobin Blood Increased	9.4% 3/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	16.2% 6/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	15.2% 5/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Investigations Blood Creatine Phosphokinase Increased	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	8.1% 3/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	12.1% 4/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Investigations White Blood Cell Count Increased	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	5.4% 2/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	3.0% 1/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Investigations Aspartate Aminotransferase Increased	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	6.1% 2/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Investigations Gamma-glutamyltransferase Increased	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	6.1% 2/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Investigations Haematocrit Decreased	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	6.1% 2/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Investigations Platelet Count Decreased	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	6.1% 2/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Investigations Troponin T Increased	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	6.1% 2/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
General disorders Pain	15.6% 5/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	13.5% 5/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	21.2% 7/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
General disorders Hypothermia	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	5.4% 2/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	9.1% 3/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
General disorders Hyperthermia	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	9.1% 3/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Blood and lymphatic system disorders Anaemia	18.8% 6/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	10.8% 4/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	18.2% 6/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Blood and lymphatic system disorders Leukocytosis	12.5% 4/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	5.4% 2/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	6.1% 2/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Cardiac disorders Bradycardia	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	5.4% 2/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	9.1% 3/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Cardiac disorders Tachycardia	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	5.4% 2/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Metabolism and nutrition disorders Hypovolaemia	3.1% 1/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	5.4% 2/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Metabolism and nutrition disorders Hyperglycaemia	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	9.1% 3/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Psychiatric disorders Confusional State	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	12.1% 4/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Psychiatric disorders Insomnia	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	0.00% 0/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Renal and urinary disorders Oliguria	0.00% 0/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	9.1% 3/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).
Respiratory, thoracic and mediastinal disorders Hypoxia	6.2% 2/32 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	2.7% 1/37 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).	3.0% 1/33 • Adverse Events observed between the onset of induction and the study end Participants at risk are the patients from the ITT Data Set (Randomised Patients).