drugset / Trial / NCT07333508
Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation
NaSequentialOpen-labelTreatment
Summary
This study aims to determine the 95% effective dose (ED95) of fospropofol disodium, a new sedative drug, for adjuvant sedation during spinal anesthesia in elderly patients (aged 65 years and older) undergoing lower extremity surgery (e.g., hip/knee replacement, lower limb fracture fixation).
Timeline
- Start
- 2026-01-01
- Primary completion
- 2026-12-31
- Completion
- 2027-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fospropofol | Small molecule | 3 mg/kg | — |
| Subject | fospropofol | Small molecule | 3.5 mg/kg | — |
| Subject | fospropofol | Small molecule | 4 mg/kg | — |
| Subject | fospropofol | Small molecule | 4.5 mg/kg | — |
| Subject | fospropofol | Small molecule | 5 mg/kg | — |
| Subject | fospropofol | Small molecule | 5.5 mg/kg | — |
| Subject | fospropofol | Small molecule | 6 mg/kg | — |
| Subject | fospropofol | Small molecule | 6.5 mg/kg | — |
| Subject | fospropofol | Small molecule | 7 mg/kg | — |
| Subject | fospropofol | Small molecule | 7.5 mg/kg | — |
| Subject | fospropofol | Small molecule | 8 mg/kg | — |
Indications
No indication recorded.