Table 3.
Secondary Outcomes Between Groups
| Measurement | Dex Group (n=30) | Lorazepam Group (n=30) | Placebo Group (n=30) | Contrast | P-value |
|---|---|---|---|---|---|
| Objective sleep measurementa | |||||
| SOL, median (IQR), min | 19.0 (16.0,22.3) | 33.5 (30.0,50.0) | 57.0 (36.8,160.5) | D-L | < 0.001 |
| D-P | < 0.001 | ||||
| L-P | 0.021 | ||||
| TST, Mean (SD), min | 403.7 (41.1) | 408.6 (55.1) | 278.8 (49.7) | D-L | >0.999 |
| D-P | < 0.001 | ||||
| L-P | < 0.001 | ||||
| SE, Mean (SD),% | 84.5 (4.9) | 83.2 (7.1) | 57.4 (9.5) | D-L | >0.999 |
| D-P | < 0.001 | ||||
| L-P | < 0.001 | ||||
| No. Of awakenings, median (IQR) | 3.0 (1.8,4.0) | 3.0 (2.0,4.0) | 5.5 (3.0,7.0) | D-L | >0.999 |
| D-P | 0.002 | ||||
| L-P | 0.005 | ||||
| WASO, median (IQR), min | 53.5 (33.8,65.5) | 41.5 (21.8,58.8) | 106.0 (62.0,164.0) | D-L | 0.898 |
| D-P | 0.002 | ||||
| L-P | < 0.001 | ||||
| Satisfaction, median (IQR)a | 9.0 (8.0,9.0) | 9.0 (8.0,9.0) | 5.0 (4.0–6.0) | D-L | >0.999 |
| D-P | < 0.001 | ||||
| L-P | < 0.001 | ||||
| Adverse reactionb | |||||
| Tachycardia, No. (%) | 0 (0) | 0 (0) | 0 (0) | D-L-P | 1.000 |
| Hypertension, No. (%) | 0 (0) | 0 (0) | 0 (0) | D-L-P | 1.000 |
| Respiratory depression, No. (%) | 0 (0) | 0 (0) | 0 (0) | D-L-P | 1.000 |
| Nasal discomfort, No. (%) | 0 (0) | 0 (0) | 0 (0) | D-L-P | 1.000 |
| Gastrointestinal discomfort, No. (%) | 0 (0) | 0 (0) | 0 (0) | D-L-P | 1.000 |
| Bitter taste, No. (%) | 1 (3) | 2 (4) | 1 (3) | D-L-P | >0.999 |
| Headache, No. (%) | 0 (0) | 3 (10) | 1 (3) | D-L-P | 0.318 |
| Unsteady gait, No. (%) | 0 (0) | 3 (10) | 1 (3) | D-L-P | 0.318 |
| Dry mouth, No. (%) | 5 (17) | 1 (3) | 2 (7) | D-L-P | 0.263 |
| Bradycardia, No. (%) | 3 (10) | 0 (0) | 0 (0) | D-L-P | 0.104 |
| Hypotension, No. (%) | 6 (20) | 3 (10) | 0 (0) | D-L | 0.472 |
| D-P | 0.024 | ||||
| L-P | 0.237 | ||||
| Dizziness, No. (%) | 1 (3) | 9 (30) | 6 (20) | D-L | 0.012 |
| D-P | 0.103 | ||||
| L-P | 0.552 | ||||
| Fatigue, No. (%) | 0 (0) | 6 (20) | 4 (13) | D-L | 0.024 |
| D-P | 0.112 | ||||
| L-P | 0.731 | ||||
| Drowsiness, No. (%) | 0 (0) | 8 (27) | 12 (40) | D-L | 0.005 |
| D-P | < 0.001 | ||||
| L-P | 0.412 |
Notes: aIn the selected outcome measures, Bonferroni correction was applied to adjust the P-values for multiple testing, with P < 0.05 considered statistically significant. bIn the selected outcome measures, the significance level was initially set at α = 0.05 for the comparisons between the three groups. When conducting pairwise comparisons between the groups, Bonferroni correction was applied with a significance level of α = 0.017, and P-value < 0.017 was considered statistically significant.
Abbreviations: SOL, Sleep Onset Latency; TST, Total Sleep Time; SE, Sleep efficiency; WASO, wake-after sleep onset.