Table 2.
Achievement of primary efficacy end point (treatment success).
| Efficacy end point | Placebo n = 70 | Remimazolam (2.5 mg) n = 71 | Remimazolam (5.0 mg) n = 71 | p Value |
|---|---|---|---|---|
| Treatment success (composite end point) | 31 (44.3%) | 55 (77.5%)a | 61 (85.9%)a | <0.001 |
| SAS score dropped below 5 within 15 min after the first does of IMP | 60 (85.7%) | 62 (87.3%) | 67 (94.4%) | 0.213 |
| No administration of rescue propofol | 31 (44.3%) | 58 (81.7%)a | 61 (85.9%)a | <0.001 |
| No recurrence of EA 15 min after the first does of IMP | 45 (64.3%) | 61 (85.9%)a | 64 (90.1%)a | <0.001 |
Data are presented as number (%) and comparisons among groups were performed using Chi-square tests. If statistical differences were identified, pairwise comparisons were performed with Bonferroni correction to account for multiple testing. Compared with Group Placebo, ap < 0.05. Compared with Group Remimazolam (2.5 mg), bp < 0.05.
SAS, Riker Sedation-Agitation Scale; IMP, investigational medicinal product; EA, emergence agitation.