Table 5.
Selected descriptive statistics for main pharmacodynamic parameters of oral remimazolam (results of part 1 of trial 2)
| PD parameter | 60 mg (N = 3) | 140 mg (N = 3) | 240 mg (N = 5) | 360 mg (N = 5) | 480 mg (N = 5) |
|---|---|---|---|---|---|
| Alertness/drowsiness VAS (Emin) | |||||
| Mean | 60.7 | 47.0 | 38.0 | 37.0 | 36.4 |
| SD | 15 | 1.0 | 16 | 5.8 | 9.3 |
| Median | 69.0 | 47.0 | 39.0 | 39.0 | 41.0 |
| MOAA/S (Emin) | |||||
| Mean | 5.0 | 5.0 | 4.8 | 4.8 | 4.6 |
| SD | 0 | 0 | 0.45 | 0.45 | 0.89 |
| Median | 5.0 | 5.0 | 5.0 | 5.0 | 5.0 |
| PAL total errors (adjusted, Emax) | |||||
| Mean | 5.67 | 17.3 | 22.8 | 11.2 | 12.6 |
| SD | 0.58 | 22 | 20 | 3.3 | 5.3 |
| Median | 6.0 | 8.0 | 14 | 11.0 | 12.0 |
| RTI 5-choice reaction time: median (Emax, ms) | |||||
| Mean | 418 | 459 | 479 | 452 | 435 |
| SD | 27 | 88 | 54 | 36 | 22 |
| Median | 404 | 416 | 483 | 452 | 436 |
Emax maximum effect, Emin minimum effect, MOAA/S modified observer’s assessment of alertness/sedation, PAL paired associated learning test, PD pharmacodynamic, RTI reaction time test, SD standard deviation, VAS visual analogue scale