Table 3.
Summary of secondary efficacy outcomes (full analysis set)
| HSK3486 (n = 134) | Propofol (n = 133) | P-value | |
|---|---|---|---|
| Time to successful induction of anesthesia/sedation, min | |||
| Median (range) | 1.00 (0.50, 3.50) | 1.00 (0.45, 8.00) | 0.059 |
| Time to fiberoptic bronchoscope insertion, min | |||
| Median (range) | 3.00 (1.12, 12.02) | 2.88 (0.97, 11.80) | 0.342 |
| Duration of fiberoptic bronchoscopy, min | |||
| Median (range) | 5.78 (2.12, 62.40) | 5.78 (1.67, 63.67) | 0.972 |
| Time to being fully alert | |||
| From extraction of fiberoptic bronchoscope, min | |||
| Median (range) | 8.50 (0.10, 27.90) | 6.00 (0.00, 29.00) | 0.012 |
| From the last drug administration, min | |||
| Median (range) | 14.33 (4.82, 30.27) | 11.93 (4.53, 35.82) | 0.001 |
| Time to discharge | |||
| From extraction of fiberoptic bronchoscope, min | |||
| Median (range) | 13.00 (4.00, 46.00) | 9.87 (3.98, 33.00) | 0.002 |
| From the last drug administration, min | |||
| Median (range) | 18.82 (8.82, 55.17) | 15.93 (8.50, 39.82) | < 0.001 |
| Experimental drugs and alternative drugs | |||
| Total times of top-up dosing | |||
| Median (range) | 0 (0, 7) | 0 (0, 9) | 0.910 |
| Number of patients with total times of top-up dosing, n (%) | |||
| 0 | 71 (53.0) | 70 (52.6) | |
| 1 | 37 (27.6) | 38 (28.6) | |
| 2 | 14 (10.4) | 15 (11.3) | |
| 3 | 9 (6.7) | 7 (5.3) | |
| 4 | 1 (0.7) | 2 (1.5) | |
| 5 | 0 (0.0) | 0 (0.0) | |
| Times of top-up dosing during the induction phase | |||
| Median (range) | 0 (0, 1) | 0 (0, 2) | 0.652 |
| Maximum times of top-up dosing in any 15-min period | |||
| Median (range) | 0 (0, 3) | 0 (0, 3) | 0.665 |
| Total dosage of top-up dosing, mg | |||
| Median (range) | 0.00 (0.00, 57.75) | 0.00 (0.00, 423.00) | < 0.001 |
| Total dosage of experimental drugs, mg | |||
| Median (range) | 26.75 (14.75, 79.50) | 142.00 (26.75, 549.00) | < 0.001 |
| No requirement for alternative drugs, n (%) | 134 (100.0) | 133 (100.0) | – |
| Anesthesia/sedation satisfaction scores | |||
| Patients | |||
| Median (range) | 10 (6, 10) | 10 (4, 10) | 0.341 |
| Anesthesiologists | |||
| Median (range) | 10 (0, 10) | 10 (1, 10) | 0.972 |
| Sufentanil and lidocaine | |||
| Top-up dosing times for sufentanil | |||
| Median (range) | 0 (0, 1) | 0 (0, 1) | 0.993 |
| Total dosage of sufentanil, mg | |||
| Median (range) | 11.80 (7.50, 19.50) | 11.90 (6.00, 20.50) | 0.686 |
| Total dosage of lidocaine, mg | |||
| Median (range) | 0.36 (0.20, 0.70) | 0.36 (0.14, 0.60) | 0.927 |
Data are presented as the median with range (minimum, maximum) or numbers with percentages in parentheses