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Desflurane Versus Propofol Anesthesia for Off-Pump CABG

M

Medical University of Gdansk

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Diprivan (propofol), Astra-Zeneca
Drug: Suprane (desflurane), Baxter

Study type

Interventional

Funder types

Other

Identifiers

NCT00528515
AMG-NKEBN/364-A/2005

Details and patient eligibility

About

The purpose of this study is to prove if anesthesia maintained with the inhaled volatile anesthetic desflurane is superior to the intravenously applied propofol anesthesia in off-pump coronary artery bypass grafting (OP-CABG) surgery as measured by following parameters:

  1. hemodynamic parameters during and after the operation,
  2. pulmonary gas exchange, need for mechanical ventilation and for ICU and intrahospital stay,
  3. release of heart muscle injury markers in response to surgery and intraoperative ischaemia,
  4. inflammatory response to the operation.

We suspect that insufflation anesthesia with desflurane may be superior to intravenous anesthesia with propofol.

Full description

General anesthesia will be induced by intravenous dosis of fentanyl, vecuronium and etomidate and further maintained either by inhaled desflurane or propofol infusion, with concomitant empirically administered fentanyl doses and continuous infusion of vecuronium.

After induction of anesthesia a Swan-Ganz catheter for continuous cardiac output, right ventricle end diastolic volume and blood saturation measurements will be introduced through the internal jugular vein. A transesophageal echocardiography probe will be placed additionally for the Tei-index measurement.

Hemodynamic parameters will be recorded at the following time points:

  • before induction
  • after induction
  • during trachea intubation
  • before skin incision
  • 3 Min. after skin incision
  • after sternotomy
  • before heart positioning for graft placing
  • before finishing placing each distal anastomoses
  • 10, 20, 30, 40 min after placing the last anastomoses
  • 10 Min. after admission to ICU, 6, 12, 18 and 24 hours after surgery.
  • TEE measurements will be obtained after sternotomy and 20 Min after placing the last distal anastomoses.

The results will be compared while using the parametric ANOVA test for normally distributed continuous data or the nonparametric Kruskal-Wallis/Wilcoxon-U test for categoric or inhomogeneous distributed continuous data.

Enrollment

80 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with coronary artery disease qualified for CABG off-pump surgery
  • Elective surgery
  • Signed informed consent

Exclusion criteria

  • Left ventricle ejection fraction < 30%
  • Serum creatinine > 2 mg/dL
  • Emergency surgery
  • Denied consent

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

1
Active Comparator group
Description:
propofol
Treatment:
Drug: Diprivan (propofol), Astra-Zeneca
2
Experimental group
Description:
desflurane
Treatment:
Drug: Suprane (desflurane), Baxter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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