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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Inhalational anesthetic; Drug: Intravenous anesthetic, propofol

• Registration Number: NCT00286585
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-02
• Study First Submitted QC: 2006-02-02
• Study First Posted: 2006-02-03
• Primary Completion: 2010-11
• Study Completion: 2011-11
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-24
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhalational anesthetic	Inhalational anesthetic	Sevoflurane will be used as the main anesthetic in this arm, and no propofol will be administered
Intravenous anesthetic, propofol	Intravenous anesthetic, propofol	Propofol will be used as the main anesthetic in this arm, and no inhalational anesthetic will be administered

Primary Outcome Measures

Name	Time	Method
Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG)	7 days postoperatively

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University Hospital; 🇨🇭 Basel, Switzerland

Kantonsspital; 🇨🇭 Liestal, Basel-Land, Switzerland

Bürgerspital; 🇨🇭 Solothurn, Switzerland