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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001979-10 |
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Enrollment rate
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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.
The inert or "noble" gas Xenon has anaesthetic properties that have been recognized 50 years ago. Several preclinical studies and investigations using xenon as an inhalational anaesthetic in humans were performed and reported that this gas has many properties of the ideal anaesthetic agent. Moreover, it is known that when xenon is combined with volatile anaesthetics or opioids, the required doses of those substances are reduced, resulting in a lower incidence of side effects. Patients could benefit from the administration of xenon if this inspired concentration would result in reduced doses of co-administered drugs.
This trial should allow evaluating the propofol consumption required in combination with xenon administered in inspiratory concentrations of 50% and 70% to maintain comparable depth of general anaesthesia as total i.v. anaesthesia, in ASA III patients presenting increased risk of perioperative cardiac complications and undergoing laparotomy or orthopaedic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Xenon 50% (45%-55%) in Oxygen (45%-55%), |
|
| Group B | Experimental | Xenon 70% (65%-75%) in Oxygen (25%-35%) |
|
| Group C | Active Comparator | Medical Air in Oxygen (45%-55%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug | Maintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min) | 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. | Maintenance period (1 Day) |
| Measure | Description | Time Frame |
|---|---|---|
| Anaesthesia Recovery Time | Time interval between the end of maintenance period and time of tracheal tube removal. | 1 Postoperative Day |
| Awakening Time | Time interval between the end of maintenance period and time of Aldrete score ≥ 9. |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Berthold BEIN, Prof Dr Med | University Hospital Schleswig-Holstein | Principal Investigator |
| Jens SCHOLZ, Prof. Dr Med | University Hospital Schleswig-Holstein | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Clermont-Ferrand | Clermont-Ferrand | 63058 | France | |||
| Groupe Hospitalier Universitaire Caremeau |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Xenon 50% (45%-55%) in Oxygen (45%-55%) |
| FG001 | Group B | Xenon 70% (65%-75%) in Oxygen (25%-35%) |
| FG002 | Group C | Medical Air in Oxygen (45%-55%) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis was done in the Intention To Treat (ITT) Data Set (Randomised Patients).
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Xenon 50% (45%-55%) in Oxygen (45%-55%) |
| BG001 | Group B | Xenon 70% (65%-75%) in Oxygen (25%-35%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min) | 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. | The main analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | mg adjusted | Maintenance period (1 Day) |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Xenon 50% (45%-55%) in Oxygen (45%-55%) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Sepsis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | Systematic Assessment |
The study has been terminated earlier due to difficulties to find patients meeting the inclusion criteria.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Med Berthold BEIN | University Hospital Schleswig-Holstein | +49(0)431-5973 739 | bein@anasthesie.uni-kiel.de |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| D000388 | Air |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D001272 |
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| Xenon | Drug | Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia. |
|
| Medical Air in Oxygen | Drug | Maintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia. |
|
| 1 Postoperative Day |
| Stay in the Operating Room | Time interval between admission in the operating room and discharge from the operating room. | 1 Postoperative Day |
| Stay in the Recovery Room | Time interval between admission in the recovery room and discharge from the recovery room. | 1 Postoperative Day |
| Haematology - Leucocytes (Giga/L) | Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery. | 1 Postoperative Day |
| Haematology - Erythrocytes (Tera/L) | Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery. | 1 Postoperative Day. |
| Haematology - Platelets (Giga/L) | Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery | 1 Postoperative Day |
| Serum Chemistry - AST (GOT) (IU/L) | AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery. | 1 Postoperative Day |
| Serum Chemistry - ALT (GPT) (IU/L) | ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery | 1 Postoperative Day |
| Serum Chemistry - Gamma GT (IU/L) | Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery | 1 Postoperative Day |
| Serum Chemistry - Creatinine (Mcmol/L) | Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery | 1 Postoperative Day |
| Serum Chemistry - Urea (mmol/L) | Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery | 1 Postoperative Day |
| Nîmes |
| 30029 |
| France |
| Evangelisches Waldkrankenhaus Berlin-Spandau | Berlin | D-14129 | Germany |
| BG Kliniken-Bergmannstrost | Halle | D-06112 | Germany |
| University Hospital Schleswig-Holstein | Kiel | D-24105 | Germany |
| Manchester Royal Infirmary | Manchester | M139WL | United Kingdom |
| BG002 |
| Group C |
Medical Air in Oxygen (45%-55%) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
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| Body Surface Area | Mean | Standard Deviation | m2 |
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| Body Mass Index | Mean | Standard Deviation | Kg/m2 |
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| Planned High-Risk Surgical Procedures | Number | participants |
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| History of Ischemic Heart Disease | Number | participants |
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| History of Congestive Heart Failure | Number | participants |
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| History of Cerebrovascular Disease | Number | participants |
|
| Pre-Operative Treatment With Insulin or Antidiabetics | Number | participants |
|
| Pre-Operative Serum Creatinine >2.0 mg/dL | Number | participants |
|
| OG001 | Group B | Xenon 70%(65%-75%) in Oxygen (25%-35%) |
| OG002 | Group C | Medical Air in Oxygen (45%-55%) |
|
|
|
| Secondary | Anaesthesia Recovery Time | Time interval between the end of maintenance period and time of tracheal tube removal. | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | minutes | 1 Postoperative Day |
|
|
|
| Secondary | Awakening Time | Time interval between the end of maintenance period and time of Aldrete score ≥ 9. | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | minutes | 1 Postoperative Day |
|
|
|
| Secondary | Stay in the Operating Room | Time interval between admission in the operating room and discharge from the operating room. | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | minutes | 1 Postoperative Day |
|
|
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| Secondary | Stay in the Recovery Room | Time interval between admission in the recovery room and discharge from the recovery room. | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | minutes | 1 Postoperative Day |
|
|
|
| Secondary | Haematology - Leucocytes (Giga/L) | Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery. | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | Giga/L | 1 Postoperative Day |
|
|
|
| Secondary | Haematology - Erythrocytes (Tera/L) | Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery. | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | Tera/L | 1 Postoperative Day. |
|
|
|
| Secondary | Haematology - Platelets (Giga/L) | Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | Giga/L | 1 Postoperative Day |
|
|
|
| Secondary | Serum Chemistry - AST (GOT) (IU/L) | AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery. | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | IU/L | 1 Postoperative Day |
|
|
|
| Secondary | Serum Chemistry - ALT (GPT) (IU/L) | ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | IU/L | 1 Postoperative Day |
|
|
|
| Secondary | Serum Chemistry - Gamma GT (IU/L) | Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery | The analysis was done in the ITT Data Set (Randomised Patients) | Posted | Mean | Standard Deviation | IU/L | 1 Postoperative Day |
|
|
|
| Secondary | Serum Chemistry - Creatinine (Mcmol/L) | Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | mcmol/L | 1 Postoperative Day |
|
|
|
| Secondary | Serum Chemistry - Urea (mmol/L) | Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery | The analysis was done in the ITT Data Set (Randomised Patients). | Posted | Mean | Standard Deviation | mmol/L | 1 Postoperative Day |
|
|
|
| 4 |
| 32 |
| 31 |
| 32 |
| EG001 | Group B | Xenon 70% (65%-75%) in Oxygen (25%-35%) | 7 | 37 | 30 | 37 |
| EG002 | Group C | Medical Air in Oxygen (45%-55%) | 5 | 33 | 32 | 33 |
| Bacteraemia | Infections and infestations | Systematic Assessment |
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| Necrotising Fasciitis | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Septic Shock | Infections and infestations | Systematic Assessment |
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| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound Decomposition | Injury, poisoning and procedural complications | Systematic Assessment |
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| Anastomotic Leak | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Oxygen Saturation Decreased | Investigations | Systematic Assessment |
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| PO2 Decreased | Investigations | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Multi-organ Failure | General disorders | Systematic Assessment |
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| Confusional State | Psychiatric disorders | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Haemorrhage | Vascular disorders | Systematic Assessment |
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| Gastrointestinal Necrosis | Gastrointestinal disorders | Systematic Assessment |
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| Megacolon | Gastrointestinal disorders | Systematic Assessment |
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| Hepatobiliary Disorders | Hepatobiliary disorders | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Procedural Hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Anaesthetic Complication Cardiac | Injury, poisoning and procedural complications | Systematic Assessment | corresponds to 1 event of "intraoperative bradycardia" |
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| Post Procedural Complication | Injury, poisoning and procedural complications | Systematic Assessment | Corresponds to 1 event of "CK rise post-operatively" (Xenon 70%group), 1 event of "slow to breathe deeply post-operatively" (Xenon 70% group) and 1 event of "post-operative bradycardia" (Medical Air group) |
|
| Procedural Nausea | Injury, poisoning and procedural complications | Systematic Assessment |
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| Anaemia Postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
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| Myoglobin Blood Increased | Investigations | Systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | Systematic Assessment |
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| White Blood Cell Count Increased | Investigations | Systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
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| Gamma-glutamyltransferase Increased | Investigations | Systematic Assessment |
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| Haematocrit Decreased | Investigations | Systematic Assessment |
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| Platelet Count Decreased | Investigations | Systematic Assessment |
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| Troponin T Increased | Investigations | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Hypothermia | General disorders | Systematic Assessment |
|
| Hyperthermia | General disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Confusional State | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Oliguria | Renal and urinary disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
| D018011 | Chalcogens |
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