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

NCT ID: NCT00286585

Last Updated: 2012-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 385 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2011-11-30

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.

Conditions

Coronary Artery Disease

Keywords

preconditioning; cardiac protection; morbidity; mortality; major non-cardiac surgery; cardiac mortality and morbidity; high cardiac perioperative risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Inhalational anesthetic

Sevoflurane will be used as the main anesthetic in this arm, and no propofol will be administered

Group Type: ACTIVE_COMPARATOR

Inhalational anesthetic

Intervention Type: DRUG

Sevoflurane, dosage according to the physician in charge

Intravenous anesthetic, propofol

Propofol will be used as the main anesthetic in this arm, and no inhalational anesthetic will be administered

Group Type: ACTIVE_COMPARATOR

Intravenous anesthetic, propofol

Intervention Type: DRUG

Propofol, dosage according to the physician in charge

Interventions

Inhalational anesthetic

Sevoflurane, dosage according to the physician in charge

Intervention Type: DRUG

Intravenous anesthetic, propofol

Propofol, dosage according to the physician in charge

Intervention Type: DRUG

Other Intervention Names

Ultane,; Sevorane; Diprivan,; Diprovan

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manfred Seeberger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, University Hospital, Basel, Switzerland

Locations

Kantonsspital

Liestal, Basel-Landschaft, Switzerland

University Hospital

Basel, Basel, Switzerland

Bürgerspital

Solothurn, Canton of Solothurn, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 27870734 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23136158 (View on PubMed)

Other Identifiers

IIS-SWIT-05-002

Identifier Type: -

Identifier Source: secondary_id

261/05

Identifier Type: -

Identifier Source: org_study_id