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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00286585
First received: February 2, 2006
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Coronary Artery Disease
Drug: Inhalational anesthetic
Drug: Intravenous anesthetic, propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) [ Time Frame: 7 days postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP]) [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
  • influence of genetic polymorphism on cardiac morbidity and mortality [ Time Frame: 7 days, 6 and 12 months ] [ Designated as safety issue: No ]
  • cardiac morbidity and mortality [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 385
Study Start Date: February 2006
Study Completion Date: November 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286585

Locations
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
Principal Investigator: Manfred Seeberger, Prof. Dr. Department of Anesthesia, University Hospital, Basel, Switzerland
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00286585     History of Changes
Other Study ID Numbers: 261/05, IIS-SWIT-05-002
Study First Received: February 2, 2006
Last Updated: August 24, 2012
Health Authority: Switzerland: Swissmedic

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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Anesthetics
Propofol
Anesthetics, Intravenous
Anesthetics, Inhalation
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on April 17, 2014