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

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

Study Description
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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
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286585


Locations
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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
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Principal Investigator: Manfred Seeberger, Prof. Dr. Department of Anesthesia, University Hospital, Basel, Switzerland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    Key Record Dates
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:
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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