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Table 1 Patient characteristics (FAS)

From: Efficacy, safety, and pharmacokinetics of MR13A11A, a generic of remifentanil, for pain management of Japanese patients in the intensive care unit: a double-blinded, fentanyl-controlled, randomized, non-inferiority phase 3 study

  

Remifentanil

N = 92

Fentanyl

N = 90

Total

N = 182

Age (y)

Mean ± SD

68.5 ± 10.9

65.9 ± 13.2

67.2 ± 12.1

Gender

Male, n (%)

69 (75.0%)

72 (80.0%)

141 (77.5%)

BMI (kg/m2)

Mean ± SD

21.54 ± 3.69

22.41 ± 3.86

21.97 ± 3.79

ICU

Internal medicine, n (%)

10 (10.9%)

15 (16.7%)

25 (13.7%)

 

Post-operation, n (%)

82 (89.1%)

75 (83.3%)

157 (86.3%)

ASA (post-operation patients) n (%)

I

7 (8.5%)

7 (9.3%)

14 (8.9%)

 

II

62 (75.6%)

48 (64.0%)

110 (70.1%)

 

III

13 (15.9%)

20 (26.7%)

33 (21.0%)

Duration of anesthesia (h) (post-operation patients) *

Mean ± SD

10.95 ± 3.64 (82)

10.73 ± 3.19 (75)

10.85 ± 3.42 (157)

Operation time (h) (post-operation patients) *

Mean ± SD

9.52 ± 3.43 (82)

9.26 ± 3.12 (75)

9.40 ± 3.28 (157)

Analgesia assessment

    

 Method

BPS, n (%)

88 (95.7%)

89 (98.9%)

177 (97.3%)

 

NRS, n (%)

4 (4.3%)

1 (1.1%)

5 (2.7%)

 BPS *

Mean ± SD

3.6 ± 1.1 (88)

3.5 ± 1.1 (89)

3.6 ± 1.1 (177)

 NRS *

Mean ± SD

2.3 ± 3.2 (4)

0.0 (1)

1.8 ± 2.9 (5)

Sedation assessment

    

 RASS, n (%)

0

31 (33.7%)

24 (26.7%)

55 (30.2%)

 

− 1

30 (32.6%)

27 (30.0%)

57 (31.3%)

 

− 2

31 (33.7%)

38 (42.2%)

69 (37.9%)

 

− 3

0

0

0

 

− 4

0

0

0

 

− 5

0

1 (1.1%)

1 (0.5%)

  1. ASA American Society of Anesthesiologist Physical Status, BMI body mass index, BPS behavioral pain scale, FAS full analysis set, ICU intensive care unit, NRS numerical rating scale, RASS Richmond agitation-sedation scale, SD standard deviation,
  2. *Data are shown as Mean ± SD (n)