Table 3.
Comparison of sedative/anesthetic pharmacodynamics between ciprofol and propofol.
| Clinical trials | Phase | Number enrolled | Groups | Dose (mg/kg) | t sedation (min) | t alert (min) | Sedation satisfaction score | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean ± SD | Median (min, max) | P | Mean ± SD | Median (min, max) | P | Mean ± SD | Median (min, max) | P | Mean ± SD | Median (min, max) | P | ||||
| Phase I clinical study in healthy subjects [23] | I | 8 | Ciprofol (iv, 1 mg/kg/h for 0.5 h + 0.4 mg/kg/h for 3.5 h) | 2.05 ± 0.45 | — | — | 12.58 ± 8.79 | — | 0.917 | 5.73 ± 2.34 | — | 0.463 | 6.8 ± 1.20 | — | 0.041 |
| 8 | Propofol (iv, 5 mg/kg/h for 0.5 h + 2 mg/kg/h for 3.5 h) | 10.88 ± 1.62 | 12.60 ± 6.90 | 6.75 ± 1.61 | 5.0 ± 2.10 | ||||||||||
| Anesthesia/sedation in patients undergoing colonoscopy [24] | IIa | 10 | Ciprofol (iv, 0.4 mg/kg) | — | — | — | 1.6 ± 0.5 | — | >0.05 | 6.0 ± 3.3a | — | <0.05 | 10.0 ± 0.0 | — | |
| 10 | Ciprofol (iv, 0.5 mg/kg) | 1.2 ± 0.4 | 10.3 ± 5.6a | 9.9 ± 0.3 | |||||||||||
| 10 | Propofol (iv, 2 mg/kg) | 1.2 ± 0.6 | 5.0 ± 3.3a | 9.6 ± 0.7 | |||||||||||
| IIb | 31 | Ciprofol (iv, 0.4 mg/kg) | — | — | — | 1.9 ± 0.6 | — | >0.05 | 6.1 ± 4.5a | — | — | 9.2 ± 1.0 | — | <0.05 | |
| 32 | Ciprofol (iv, 0.5 mg/kg) | 1.5 ± 0.3 | 5.1 ± 2.9a | 9.5 ± 0.8 | |||||||||||
| 31 | Propofol (iv, 2 mg/kg) | 1.5 ± 0.4 | 4.3 ± 3.3a | 9.2 ± 0.9 | |||||||||||
| Induction of deep sedation during gastroscopy and colonoscopy procedures [25] | III | 144 | Ciprofol (iv, 0.4 mg/kg) | — | — | — | 1.1 ± 0.5 | — | 0.405 | 3.3 ± 3.1 | — | <0.001 | 9.9 ± 0.4 | — | 0.001 |
| 145 | Propofol (iv, 1.5 mg/kg) | 1.1 ± 0.4 | 2.0 ± 2.1 | 9.7 ± 0.7 | |||||||||||
| Anesthesia/sedation in patients undergoing fiber-optic bronchoscopy [26] | III | 134 | Ciprofol (iv, 0.4 mg/kg) | — | 26.75 (14.75, 79.50) | <0.001 | — | 1.00 (0.50, 3.50) | 0.059 | — | 8.50 (0.10, 27.90) | 0.012 | — | 10 (6, 10) | 0.341 |
| 133 | Propofol (iv, 2 mg/kg) | 142.00 (26.75, 549.00) | 1.00 (0.45, 8.00) | 6.00 (0.00, 29.00) | 10 (4, 10) | ||||||||||
| Induction/maintenance of general anesthesia in elective surgery [27, 28] | II | 30 | Ciprofol (iv, 0.4 mg/kg + 1 mg/kg/h for 6 patients and 0.8 mg/kg/h for 24 patients) | — | — | — | 45.3 ± 14.8 | — | 0.840c | 11.4 ± 4.9 | — | 0.575c | 11.8 ± 0.8d 11.3 ± 1.1e |
— | 0.024d 0.814e |
| 10 | Propofol (iv, 2 mg/kg + 5 mg/kg/h for 2 patients and 6 mg/kg/h for 8 patients) | 42.3 ± 15.3 | 11.8 ± 3.4 | 10.6 ± 2.4d 11.4 ± 1.3e |
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| 6 | Propofol (iv, 2 mg/kg)+ciprofol (iv, 1 mg/kg/h) | 56.7 ± 13.7 | 13.5 ± 4.6 | 11.2 ± 2.0d 10.3 ± 2.0e |
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| III | 88 | Ciprofol (0.4 mg/kg, bolus iv over 30 s) | 26.0 ± 5.8b | — | — | 0.91 ± 0.03 | — | <0.05 | — | — | — | 10.9 ± 1.4 | — | 0.496 | |
| 88 | Propofol (2 mg/kg, bolus iv over 30 s) | 121.8 ± 24.6b | 0.80 ± 0.03 | 10.8 ± 1.4 | |||||||||||
| Sedation in ICU patients with mechanical ventilation [29, 30] | II | 26 | Ciprofol (iv, 0.1-0.2 mg/kg/h for 0.5 − 5 min + 0.3 mg/kg/h) | — | 0.3 (0.1, 0.5) | <0.001 | — | 60.0 (52.6, 60.0) | — | — | 4.0 (0.0, 29.4) | 0.418 | — | 1.0 (1.0, 2.0)f | 0.521 |
| 13 | Propofol (iv, 0.5-1 mg/kg/h for 0.5 − 5 min + 1.5 mg/kg/h) | 1.5 (1.1, 1.6) | 60.0 (55.2, 60.0) | 4.5 (3.3, 24.6) | 1.0 (1.0, 2.0)f | ||||||||||
Notes: atime to alert from colonoscope withdrawal; btotal dose (mg); cciprofol group vs. propofol group; dinduction period; emaintenance period; fnursing score, overall evaluation of adaptive capacity for endotracheal intubation and mechanical ventilation; — indicates the data is not available. Abbreviations: tsedation: time to onset of anesthesia/sedation; talert: time to full alertness or recovery from anesthesia/sedation.