Comparison of Ropivacaine and Levobupivacaine in High Thoracic Epidural Anesthesia
Condition: Coronary Artery Bypass; Epidural Anesthesia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The use of high thoracic epidural, combined with general anesthesia (HTEA) in patients
      undergoing cardiac surgery has become increasing popular in recent years. In fact, this
      technique is potentially beneficial because of the attenuation of the stress response to
      surgery, the sympathetic tone reduction and the excellent postoperative analgesia.Patients
      submitted to coronary artery bypass graft will be randomly allocated to receive high epidural
      block with ropivacaine (R) or levobupivacaine (L), supplemented with sufentanil, during and
      after surgery. Postoperatively, the rate of epidural infusion will be modified to maintain a
      VAS score less than 4 in the thoracic area when coughing. VAS, total amount and rate of
      epidural drug infusion, MAP, total amount and rate of norepinephrine infusion and motor block
      will be recorded on arrival in the ICU, on awakening and after 4, 8, 12, 24 hours.
      Additionally, the onset time of the epidural sensory block, the time of awakening and the
      time on ventilator will be recorded as well as episodes of postoperative nausea and vomiting
      (PONV) and pruritus.
    

Intervention name(s): Ropivacaine; Levobupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 0.5% epidural bolus injection (0.1 mL kg-1) with sufentanil 2.5 µg mL-1 before general anesthesia induction, followed by 0.2% infusion (0.1 mL kg-1 h-1) with sufentanil 1 µg mL-1 throughout surgery; in ICU, 0.1% epidural infusion with sufentanil 1µg mL-1 at 0.1 mL kg-1 h-1 and the rate is modified following this protocol: on awakening (Ramsay 2) VAS on coughing is evaluated: if it is 4 the infusion rate is not changed, if the VAS is ≥ 4 the rate is increased by 2 mL h-1 after giving a 2 mL bolus and VAS is checked again 30 minutes later, if it is ≤ 4 the infusion rate is decreased by 2 mL h-1.; 0.5% epidural bolus injection (0.1 mL kg-1) with sufentanil 2.5 µg mL-1 before general anesthesia induction, followed by 0.2% infusion (0.1 mL kg-1 h-1) with sufentanil 1 µg mL-1 throughout surgery; in ICU, 0.1% epidural infusion with sufentanil 1µg mL-1 at 0.1 mL kg-1 h-1 and the rate is modified following this protocol: on awakening (Ramsay 2) VAS on coughing is evaluated: if it is 4 the infusion rate is not changed, if the VAS is ≥ 4 the rate is increased by 2 mL h-1 after giving a 2 mL bolus and VAS is checked again 30 minutes later, if it is ≤ 4 the infusion rate is decreased by 2 mL h-1.
Other intervention name(s): Naropina; Chirocaina
Intervention MeSH terms: Ropivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment