Remifentanil versus fentanyl for analgesia based sedation to provide patient comfort in the intensive care unit: a randomized, double-blind controlled trial [ISRCTN43755713]

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 (CL_cr), as described by Cockcroft and Gault [32]. *Normal renal function was defined as a predicted CL_cr >80 ml/min. ^†Mild renal impairment was defined as a predicted CL_cr of 50–80 ml/min. ITT, intent to treat population; SD, standard deviation; SP, safety population.

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