Table 2.
Patient demographic and clinical characteristics
Characteristic | Remifentanil | Fentanyl |
Number of patients treated (SP) | 115 | 81 |
Open label pilot patients | 12 | 6 |
Open label practice patients | 26 | 0 |
ITT population | 77 | 75 |
Cardiac postsurgical | 46 (60%) | 45 (60%) |
General postsurgical | 25 (32%) | 26 (35%) |
Medical | 6 (8%) | 4 (5%) |
Normal renal function* | 68 (59%) | 48 (59%) |
Mild renal impairment† | 47 (41%) | 33 (41%) |
Mean SAPS II (SD) | SP 27.9 (8.7); ITT 28.2 (8.8) | SP 27.6 (8.6); ITT 27.7 (8.8) |
Mean age [years] (SD) | SP 61.3 (13.8); ITT 61.5 (13.4) | SP 59.3 (13.6); ITT 58.7 (13.9) |
Sex | ||
Male | SP 81 (70%); ITT 55 (71%) | SP 56 (69%); ITT 52 (69%) |
Female | SP 34 (30%); ITT 22 (29%) | SP 25 (31%); ITT 23 (31%) |
Mean height (cm; SD) | SP 169.8 (9.5); ITT 170.4 (9.1) | SP 169.7 (9.8); ITT 169.6 (9.6) |
Mean weight (kg; SD) | SP 76.9 (13.9); ITT 77.2 (12.7) | SP 74.9 (13.0); ITT 74.8 (13.9) |
Renal function was assessed by predicting the patient's creatinine clearance (CLcr), as described by Cockcroft and Gault [32]. *Normal renal function was defined as a predicted CLcr >80 ml/min. †Mild renal impairment was defined as a predicted CLcr of 50–80 ml/min. ITT, intent to treat population; SD, standard deviation; SP, safety population.