Overview

Comparison of Ropivacaine and Levobupivacaine in High Thoracic Epidural Anesthesia

Status:
Completed
Trial end date:
2005-06-01
Target enrollment:
0
Participant gender:
All
Summary
In High Thoracic Epidural Anesthesia (HTEA) the use of a local anesthetic (LA) with low cardiac toxicity is crucial as myocardial contractility is often already seriously impaired. The aim of this study is to compare the efficacy, doses and side effects of ropivacaine and levobupivacaine in patients submitted to coronary artery bypass graft with HTEA and general anesthesia. The primary end point is the amount of LA drug required to maintain a VAS < 4 when coughing in the first 24 postoperative hours.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centro Cardiologico Monzino
Treatments:
Anesthetics
Bupivacaine
Levobupivacaine
Ropivacaine
Criteria
Inclusion Criteria:

- Patients scheduled for coronary artery bypass grafting

- with stable angina

- left ventricular ejection fraction > 30%

- age > 18 years

- having signed a written informed consent.

- Prothrombin Time (PT) > 80% and Partial Thromboplastin Time (PTT) within the normal
range, and platelet counts (PLT) > 100.000 /mL

Exclusion Criteria:

- emergency operation

- known coagulation disorders or recent thrombolytic therapy

- angina on arrival in the operating room

- acute myocardial infarction within the previous seven days

- clinically significant associated valvular disease

- known neuraxial pathology

- patients participating in other clinical research protocols.