TEAM-Project: Trial on the Effect of Anesthetics on Morbidity and Mortality
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Inhalational anesthetic Drug: Intravenous anesthetic, propofol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) [ Time Frame: 7 days postoperatively ] [ Designated as safety issue: No ]
- Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP]) [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
- influence of genetic polymorphism on cardiac morbidity and mortality [ Time Frame: 7 days, 6 and 12 months ] [ Designated as safety issue: No ]
- cardiac morbidity and mortality [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 385 |
| Study Start Date: | February 2006 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Inhalational anesthetic
Sevoflurane will be used as the main anesthetic in this arm, and no propofol will be administered
|
Drug: Inhalational anesthetic
Sevoflurane, dosage according to the physician in charge
Other Names:
|
|
Active Comparator: Intravenous anesthetic, propofol
Propofol will be used as the main anesthetic in this arm, and no inhalational anesthetic will be administered
|
Drug: Intravenous anesthetic, propofol
Propofol, dosage according to the physician in charge
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
More Information
No publications provided by University Hospital, Basel, Switzerland
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT00286585 History of Changes |
| Other Study ID Numbers: | 261/05, IIS-SWIT-05-002 |
| Study First Received: | February 2, 2006 |
| Last Updated: | August 24, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University Hospital, Basel, Switzerland:
|
preconditioning cardiac protection morbidity mortality |
major non-cardiac surgery cardiac mortality and morbidity high cardiac perioperative risk |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Anesthetics Propofol |
Anesthetics, Intravenous Anesthetics, Inhalation Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, General Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 23, 2013