TEAM-Project: Trial on the Effect of Anesthetics on Morbidity and Mortality
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ClinicalTrials.gov Identifier: NCT00286585 |
Recruitment Status :
Completed
First Posted : February 3, 2006
Last Update Posted : August 27, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Drug: Inhalational anesthetic Drug: Intravenous anesthetic, propofol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 385 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Multi-Center Trial on the Effect of Anesthetics on Morbidity and Mortality in Patients Undergoing Major Non-cardiac Surgery |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
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Active Comparator: Inhalational anesthetic
Sevoflurane will be used as the main anesthetic in this arm, and no propofol will be administered
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Drug: Inhalational anesthetic
Sevoflurane, dosage according to the physician in charge
Other Names:
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Active Comparator: Intravenous anesthetic, propofol
Propofol will be used as the main anesthetic in this arm, and no inhalational anesthetic will be administered
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Drug: Intravenous anesthetic, propofol
Propofol, dosage according to the physician in charge
Other Names:
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- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286585
Switzerland | |
Kantonsspital | |
Liestal, Basel-Land, Switzerland, CH-4410 | |
University Hospital | |
Basel, Switzerland, CH-4000 | |
Bürgerspital | |
Solothurn, Switzerland, CH-4500 |
Principal Investigator: | Manfred Seeberger, Prof. Dr. | Department of Anesthesia, University Hospital, Basel, Switzerland |
Responsible Party: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT00286585 |
Other Study ID Numbers: |
261/05 IIS-SWIT-05-002 |
First Posted: | February 3, 2006 Key Record Dates |
Last Update Posted: | August 27, 2012 |
Last Verified: | August 2012 |
preconditioning cardiac protection morbidity mortality |
major non-cardiac surgery cardiac mortality and morbidity high cardiac perioperative risk |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Propofol Anesthetics, Intravenous Anesthetics Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, General |