TEAM-Project: Trial on the Effect of Anesthetics on Morbidity and Mortality

• ClinicalTrials.gov Identifier: NCT00286585
• Recruitment Status: Completed
• First Posted: February 3, 2006
• Last Update Posted: August 27, 2012
• Sponsor: University Hospital, Basel, Switzerland
• Collaborator: Abbott
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Drug: Inhalational anesthetic; Drug: Intravenous anesthetic, propofol	Phase 4

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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: Ultane,; Sevorane
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: Diprivan,; Diprovan

Outcome Measures

Primary Outcome Measures :

1. Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) [ Time Frame: 7 days postoperatively ]

Secondary Outcome Measures :

1. Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP]) [ Time Frame: 2 days postoperatively ]
2. influence of genetic polymorphism on cardiac morbidity and mortality [ Time Frame: 7 days, 6 and 12 months ]
3. cardiac morbidity and mortality [ Time Frame: 6 and 12 months ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

Switzerland

Kantonsspital

Liestal, Basel-Land, Switzerland, CH-4410

University Hospital

Basel, Switzerland, CH-4000

Bürgerspital

Solothurn, Switzerland, CH-4500

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Abbott

Investigators

• Principal Investigator: Manfred Seeberger, Prof. Dr.; Department of Anesthesia, University Hospital, Basel, Switzerland

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• 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
• Last Update Posted: August 27, 2012
• Last Verified: August 2012

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; 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