TABLE 2.
Summary of adverse events (AEs)
| AEs | Remimazolam (n = 200) | Propofol (n = 200) | p value |
|---|---|---|---|
| All AEs, n | 87 | 204 | / |
| Patients with AEs | 82 (41.0) | 141 (70.5) | <0.001 a |
| Specific AEs | / | ||
| Hypotension | 73 (36.5) | 139 (69.6) | <0.001 a |
| Bradycardia | 3 (1.5) | 17 (8.5) | 0.001 a |
| Respiratory depression | 9 (4.5) | 20 (10.0) | 0.034 a |
| Hypoxemia | 2 (1.0) | 4 (2.0) | 0.411 |
| Pain at injection site | 0 | 24 (12.0) | <0.001 a |
| Inability to ambulate | 0 | 0 | / |
| Nausea | 0 | 0 | / |
| Vomiting | 0 | 0 | / |
| Dizziness | 0 | 0 | / |
| Delirium | 0 | 0 | / |
| Vasoactive drug use | 24 (12.0) | 77 (38.5) | <0.001 a |
Note: Data are expressed as n(%). Hypotension was defined as systolic blood pressure ≤ 90 mmHg or greater than 30% decline from baseline; bradycardia was defined as a heart rate ≤ 50 per minute; respiratory depression is defined as a respiratory rate less than eight breaths per minute and/or SpO2 < 90%; hypoxemia was defined as SpO2 < 90%.
a
p < 0.05.