Table 4.
Adverse events in the four treatment groups n (%)
| Adverse events |
Group |
|||
| Cs (n = 43) | Cc (n = 43) | Ns (n = 41) | Nc (n = 41) | |
| Hypoxemia (SpO2 < 90% for ≥ 15 s) | 4 (9.3)a | 12 (27.9) | 3 (7.3) | 5 (12.2) |
| SpO2 89%-80% | 2 (4.7) | 5 (11.2) | 2 (4.9) | 3 (7.3) |
| SpO2 79%-60% | 2 (4.7) | 5 (11.2) | 1 (2.4) | 2 (4.9) |
| SpO2 59%-40% | 0 (0.0) | 1 (2.3) | 0 (0.0) | 0 (0.0) |
| SpO2 < 40% | 0 (0.0) | 1 (2.3) | 0 (0.0) | 0 (0.0) |
| Average decrease in value of SpO2 | 2.3 ± 5.4a | 7.3 ± 12.6 | 1.7 ± 4.3 | 2.6 ± 5.8 |
| Hypotension (SBP < 90 mmHg or DBP < 60 mmHg) | 0 (0.0) | 1 (2.3) | 0 (0.0) | 0 (0.0) |
| Extent of SBP decrease | ||||
| ≤ 10 | 28 (65.1) | 17 (39.5) | 34 (82.9) | 28 (68.3) |
| 11-20 | 15 (34.9)a | 26 (60.5) | 7 (17.1) | 13 (31.7) |
| > 20 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Average decrease in value of SBP | 10.4 ± 3.3b | 15.1 ± 6.8 | 10.2 ± 3.3 | 10.6 ± 4.5 |
| Extent of DBP decrease | ||||
| ≤ 10 | 40 (93.0) | 34 (79.1) | 37 (90.2) | 38 (92.7) |
| 11-20 | 3 (7.0) | 9 (20.9) | 4 (9.8) | 3 (7.3) |
| > 20 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Average decrease in value of DBP | 7.9 ± 2.2b | 9.5 ± 1.8 | 7.6 ± 2.6 | 8.0 ± 1.7 |
| Tachycardia (> 100 bpm) | 3 (7.0) | 2 (4.7) | 2 (4.9) | 1 (2.4) |
| Bradycardia (< 60 bpm) | 3 (7.0) | 6 (14.0) | 3 (7.3) | 4 (9.8) |
| Decrease of pulse rate | 33 (76.7) | 36 (83.7) | 29 (70.7) | 28 (68.3) |
| Increase of pulse rate | 8 (18.6) | 6 (14.0) | 8 (19.5) | 8 (19.5) |
| No change of pulse rate | 2 (4.7) | 1 (2.3) | 4 (9.8) | 5 (12.2) |
| Average change in value of pulse rate | 0.6 ± 2.8a | 2.2 ± 2.8 | 0.7 ± 2.4 | 1.4 ± 2.5 |
| Arrhythmias | 2 (4.7) | 1 (2.3) | 1 (2.4) | 0 (0.0) |
| Other adverse events | 3 (7.0) | 5 (11.6) | 2 (4.9) | 3 (7.3) |
| Extrapyramidal reactions | 0 (0.0) | 1 (2.3) | 0 (0.0) | 0 (0.0) |
| Somnolence | 1 (2.3) | 2 (4.7) | 1 (2.4) | 1 (2.4) |
| Dizziness | 2 (4.7) | 2 (4.7) | 1 (2.4) | 2 (4.9) |
| Overall rate of adverse events | 15 (34.9)b | 27 (62.8) | 11 (26.8) | 13 (31.7) |
Group Cs: Chronic obstructive pulmonary disease (COPD) with stepwise sedation; Group Cc: COPD with continuous sedation; Group Ns: Non-COPD with stepwise sedation; Group Nc: Non-COPD with continuous sedation; SpO2: Saturation of peripheral oxygen; SBP: Systolic blood pressure; DBP: Diastolic blood pressure. Overall rate of adverse events included hypoxemia, hypotension, tachycardia, bradycardia, arrhythmias and other adverse events.
a
P < 0.05,
b
P < 0.01 vs Group Cc.