Table 3 Summary of efficacy (FAS)

Primary endpoint

Proportion of the patients who did not require rescue analgesics (%)*

100.0 [96.1, 100.0]

97.8 [92.2, 99.7]

2.2 [ − 0.8, 5.3]

No. of patients who did not require rescue analgesics

92

88

–

Secondary endpoints

No. of rescue analgesics doses^†

0.00 ± 0.00 [–, –]

0.03 ± 0.23 [− 0.02, 0.08]

–

Total dose of rescue analgesics^† (µg/kg)

0.00 ± 0.00 [–, –]

0.02 ± 0.12 [− 0.01, 0.04]

− 0.02 [− 0.04, 0.01]

Concomitant use of sedatives

Yes, n (%)

78 (84.8%)

78 (86.7%)

 Propofol (mg)^†

435.66 ± 744.62

[281.45, 589.86]

693.22 ± 1613.79

[355.22, 1031.22]

− 257.56

[-623.89, 108.77]

 Dexmedetomidine (µg)^†

158.51 ± 186.92

[119.80, 197.22]

236.47 ± 494.56

[132.89, 340.06]

− 77.96

[− 186.87, 30.95]

Proportion of duration maintained BPS ≤ 5 or NRS ≤ 3 (%)^†

99.16 ± 2.60

[98.62, 99.70]

98.50 ± 3.44

[97.78, 99.22]

0.66

[− 0.24, 1.55]

Proportion of duration maintained RASS ≤ 0 (%)^†

99.54 ± 1.53

[99.22, 99.85]

99.07 ± 3.69

[98.30, 99.84]

0.47

[− 0.36, 1.29]

Proportion of duration maintained RASS = − 2 to 0 (%)^†

89.66 ± 24.24

[84.64, 94.68]

83.86 ± 28.92

[77.81, 89.92]

5.80

[− 2.00, 13.60]

Duration from the end of dosing to weaning from the ventilator (h)^†

1.68 ± 4.31

[0.79, 2.57]

1.17 ± 2.68

[0.61,1.74] ‡

0.51

[− 0.55, 1.57]

Duration from the start of dose-reduction toward the ventilator weaning (h)^†

1.89 ± 4.29

[1.00, 2.78]

1.45 ± 2.78

[0.86, 2.04] ‡

0.44

[− 0.63, 1.51]