A Phase 4 interventional study of Inhalational anesthetic and Intravenous anesthetic, propofol in Coronary Artery Disease, sponsored by University Hospital, Basel, Switzerland. Completed at 3 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-27.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Prevention
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 385 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Sevoflurane will be used as the main anesthetic in this arm, and no propofol will be administered
Drug: Inhalational anesthetic
Propofol will be used as the main anesthetic in this arm, and no inhalational anesthetic will be administered
Drug: Intravenous anesthetic, propofol
Sevoflurane, dosage according to the physician in charge
Also known as: Ultane,, Sevorane
Propofol, dosage according to the physician in charge
Also known as: Diprivan,, Diprovan
Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG)
Time frame: 7 days postoperatively
Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP])
Time frame: 2 days postoperatively
influence of genetic polymorphism on cardiac morbidity and mortality
Time frame: 7 days, 6 and 12 months
cardiac morbidity and mortality
Time frame: 6 and 12 months
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland