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

Coronary Artery Disease Clinical Trial

Official title:

Multi-Center Trial on the Effect of Anesthetics on Morbidity and Mortality in Patients Undergoing Major Non-cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286585
• Other study ID #: 261/05
• Secondary ID: IIS-SWIT-05-002
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2006
• Last updated: August 24, 2012
• Start date: February 2006
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Inhalational anesthetic
Sevoflurane, dosage according to the physician in charge
• Intravenous anesthetic, propofol
Propofol, dosage according to the physician in charge

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel
Switzerland	Kantonsspital	Liestal	Basel-Land
Switzerland	Bürgerspital	Solothurn

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Abbott

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG)		7 days postoperatively	No
Secondary	Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP])		2 days postoperatively	No
Secondary	influence of genetic polymorphism on cardiac morbidity and mortality		7 days, 6 and 12 months	No
Secondary	cardiac morbidity and mortality		6 and 12 months	No