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

NCT00286585 | Completed Phase 4 DMC

• 2 other identifiers: 261/05IIS-SWIT-05-002
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG)

  7 days postoperatively

Secondary Outcomes (3)

• 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

Study Arms (2)

Inhalational anesthetic

ACTIVE COMPARATOR

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

Drug: Inhalational anesthetic

Intravenous anesthetic, propofol

ACTIVE COMPARATOR

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

Drug: Intravenous anesthetic, propofol

Interventions

Inhalational anesthetic DRUG

Sevoflurane, dosage according to the physician in charge

Also known as: Ultane,, Sevorane

Inhalational anesthetic

Intravenous anesthetic, propofol DRUG

Propofol, dosage according to the physician in charge

Also known as: Diprivan,, Diprovan

Intravenous anesthetic, propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Abbott: collaborator

Study Sites (3)

Kantonsspital

Liestal, Basel-Landschaft, CH-4410, Switzerland

Location

University Hospital

Basel, Basel, CH-4000, Switzerland

Location

Bürgerspital

Solothurn, Canton of Solothurn, CH-4500, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 27870734 DERIVED

• 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.

  PMID: 23136158 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Sevoflurane; Anesthetics, Intravenous; Propofol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Manfred Seeberger, Prof. Dr.

  Department of Anesthesia, University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 3, 2006
• Study Start: February 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2011
• Last Updated: August 27, 2012

Record last verified: 2012-08

Locations

CH (3)