Clinical trial NCT00286585: TEAM-Project: Trial on the Effect of Anesthetics on Morbidity and Mortality
Official title: Multi-Center Trial on the Effect of Anesthetics on Morbidity and Mortality in Patients Undergoing Major Non-cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: preconditioning
cardiac protection
morbidity
mortality
major non-cardiac surgery
cardiac mortality and morbidity
high cardiac perioperative risk
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2006-02-03
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a non-cardiac surgical procedure of high or intermediate cardiac risk are eligible if they have documented coronary artery disease (CAD) or are at high risk of CAD.

Exclusion Criteria:

* Ongoing medication with sulfonylurea derivatives (unless stopped ≥ 2 days before surgery) or theophylline
* Emergency surgery
* Unstable angina pectoris
* Preoperative hemodynamic instability
* Severe hepatic disease
* Renal insufficiency (creatinine clearance \< 30 ml/min)
* Severe chronic obstructive pulmonary disease (forced expiratory volume in 1 second \[FEV1\] \< 1 litre)
* Absence of written patient consent

Primary outcomes:
measure: Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG)
timeFrame: 7 days postoperatively
Secondary outcomes:
measure: Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP])
timeFrame: 2 days postoperatively
measure: influence of genetic polymorphism on cardiac morbidity and mortality
timeFrame: 7 days, 6 and 12 months
measure: cardiac morbidity and mortality
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Kantonsspital
state: Basel-Land
city: Basel
country: Switzerland
facility: University Hospital
city: Solothurn
country: Switzerland
facility: Bürgerspital
Study officials:
affiliation: Department of Anesthesia, University Hospital, Basel, Switzerland
name: Manfred Seeberger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.