Search

This multi-centre, parallel group, randomized, double-blind study compared the efficacy and safety of high-dose remifentanil administered by continuous infusion with an intermittent bolus fentanyl regimen, when given in combination with propofol for general anaesthesia in 321 patients undergoing elective coronary artery bypass graft surgery. A significantly lower proportion of the patients who received remifentanil had responses to maximal sternal spread (the primary efficacy endpoint) compared with those who received fentanyl (11% vs 52%; P<0.001). More patients who received remifentanil responded to tracheal intubation compared with those who received fentanyl (24% vs 9%; P<0.001). However, fewer patients who received remifentanil responded to sternal skin incision (11% vs 36%; P<0.001) and sternotomy (14% vs 60%; P <0.001). Median time to extubation was longer in the subjects who received remifentanil than for those who received fentanyl (5.1 vs 4.2 h; P=0.006). There were no statistically significant differences between the two groups in the times for transfer from intensive care unit or hospital discharge but time to extubation was significantly longer in the remifentanil group. Overall, the incidence of adverse events was similar but greater in the remifentanil group with respect to shivering (P<0.049) and hypertension (P<0.001). Significantly more drug-related adverse events were reported in the remifentanil group (P=0.016). There were no drug-related adverse cardiac outcomes and no deaths from cardiac causes before hospital discharge in either treatment group.

A pulsatile, membrane type pump, TPP, was developed for use in routine cardiac surgery. The artificial ventricle consists of a polycarbonate housing with an inlet and outlet polyurethane tricuspid valve. The membrane is actuated hydraulically. For pre-clinical studies, we designed a study in sheep. After a pump run of 6 hours the animals were allowed to recover and sacrificed after 72 hours. All clinical parameters returned to normal values (p>0.05 vs. control values). During pump run we found elevated free plasma hemoglobine. However, these values returned to normal until the end of the observation period. Thereafter, the device was used in ten routine cardiac surgery procedures. All patients survived the procedure and were discharged from hospital. The postoperative course of lab parameters (kidney, liver and blood count) was no different to routine cardiac surgical procedures. This pulsatile pump system can thus be safely employed in cardiac surgery.