Comparative efficacy and safety of remifentanil and fentanyl in 'fast track' coronary artery bypass graft surgery: a randomized, double-blind study

This multi-centre, parallel group, randomized, double-blindstudy compared the efficacy and safety of high-dose remifentaniladministered by continuous infusion with an intermittent bolusfentanyl regimen, when given in combination with propofol forgeneral anaesthesia in 321 patients undergoing elective coronaryartery bypass graft surgery. A significantly lower proportionof the patients who received remifentanil had responses to maximalsternal spread (the primary efficacy endpoint) compared withthose who received fentanyl (11% vs 52%; P<0.001). More patientswho received remifentanil responded to tracheal intubation comparedwith those who received fentanyl (24% vs 9%; P<0.001). However,fewer patients who received remifentanil responded to sternalskin incision (11% vs 36%; P<0.001) and sternotomy (14% vs60%; P <0.001). Median time to extubation was longer in thesubjects who received remifentanil than for those who receivedfentanyl (5.1 vs 4.2 h; P=0.006). There were no statisticallysignificant differences between the two groups in the timesfor transfer from intensive care unit or hospital dischargebut time to extubation was significantly longer in the remifentanilgroup. Overall, the incidence of adverse events was similarbut greater in the remifentanil group with respect to shivering(P<0.049) and hypertension (P<0.001). Significantly moredrug-related adverse events were reported in the remifentanilgroup (P=0.016) There were no drug-related adverse cardiac outcomesand no deaths from cardiac causes before hospital dischargein either treatment group. Br J Anaesth 2001; 87: 718–26