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| ID | Type | Description | Link |
|---|---|---|---|
| IIS-SWIT-05-002 |
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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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Volatile anesthetics may provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. In patients undergoing coronary artery bypass surgery, this preconditioning effect resulted in better cardiac performance, faster recovery and lower morbidity and mortality.
The investigators will perform a prospective randomized multi-center study to compare volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo major non-cardiac surgery.
Basic research and animal studies have detected that volatile anesthetics provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. Recent clinical studies have found that this preconditioning effect is of clinical relevance in patients undergoing coronary artery bypass surgery, resulting in better cardiac function and faster recovery after surgery, and in lower one-year morbidity. In patients undergoing non cardiac surgery, cardiac complications also are the major cause of perioperative morbidity and mortality. Myocardial ischemia frequently occurs during and immediately after non cardiac surgery in patients with coronary artery disease, and is a strong predictor of subsequent cardiac complications and death. Whether or not volatile anesthetics also provide clinically relevant protection from perioperative ischemia and subsequent cardiac complications in patients undergoing non cardiac surgery is unknown. Therefore, we will perform a prospective, randomized multi-center study to compare volatile with total intravenous anesthesia in patients at high cardiac risk who undergo major non cardiac surgery. We hypothesize that the use of a volatile anesthetic will reduce the incidence of perioperative ischaemia and myocardial injury, as indicated primarily by less ST-segment changes in the Holter ECG and, if there will be an effect, secondarily by lower incidences of elevated troponin T and NT-pro-BNP levels. And we hypothesize that the use of a volatile anesthetic will reduce the one-year incidence of cardiac complications and all cause mortality after surgery. The results of this study may apply to a huge percentage of surgical patients because coronary artery disease is the clinically most relevant co-morbidity, and its prevalence is expected to increase with the steadily increasing number of surgical patients aged 65 yr and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhalational anesthetic | Active Comparator | Sevoflurane will be used as the main anesthetic in this arm, and no propofol will be administered |
|
| Intravenous anesthetic, propofol | Active Comparator | Propofol will be used as the main anesthetic in this arm, and no inhalational anesthetic will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhalational anesthetic | Drug | Sevoflurane, dosage according to the physician in charge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) | 7 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP]) | 2 days postoperatively | |
| influence of genetic polymorphism on cardiac morbidity and mortality | 7 days, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manfred Seeberger, Prof. Dr. | Department of Anesthesia, University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital | Liestal | Basel-Landschaft | CH-4410 | Switzerland | ||
| University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27870734 | Derived | Mauermann E, Bolliger D, Seeberger E, Puelacher C, Corbiere S, Filipovic M, Seeberger M, Mueller C, Lurati Buse G. Incremental Value of Preoperative Copeptin for Predicting Myocardial Injury. Anesth Analg. 2016 Dec;123(6):1363-1371. doi: 10.1213/ANE.0000000000001635. | |
| 23136158 | Derived | Lurati Buse GA, Schumacher P, Seeberger E, Studer W, Schuman RM, Fassl J, Kasper J, Filipovic M, Bolliger D, Seeberger MD. Randomized comparison of sevoflurane versus propofol to reduce perioperative myocardial ischemia in patients undergoing noncardiac surgery. Circulation. 2012 Dec 4;126(23):2696-704. doi: 10.1161/CIRCULATIONAHA.112.126144. Epub 2012 Nov 7. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D018686 | Anesthetics, Intravenous |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Intravenous anesthetic, propofol | Drug | Propofol, dosage according to the physician in charge |
|
|
| cardiac morbidity and mortality | 6 and 12 months |
| Basel |
| Basel |
| CH-4000 |
| Switzerland |
| Bürgerspital | Solothurn | Canton of Solothurn | CH-4500 | Switzerland |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D018681 | Anesthetics, General |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |