NCT07333508

Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation

95% Effective Dose (ED95) of Fospropofol Disodium for Adjunctive Sedation During Spinal Anesthesia in Elderly Patients Undergoing Lower Extremity Surgery

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ya-Qun Zhou · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Fospropofol disodium, the only water-soluble propofol prodrug marketed in China, features mild effects on respiratory and circulatory systems, low injection pain, no lipid metabolism-related adverse reactions, and suitable duration of action-making it a promising sedative for elderly patients. However, clinical data on its use in adjuvant sedation during spinal anesthesia are lacking, with no reports on its effective dose in this specific scenario. This prospective sequential trial aims to determine the 95% effective dose (ED95) of fospropofol disodium for sedation induction and maintenance in elderly patients (≥65 years) undergoing lower extremity surgery with spinal anesthesia, providing evidence-based guidance for safe and rational clinical use.

Conditions

• Lower Extremity Surgery

Interventions

Type	Name	Description
DRUG	Fospropofol Disodium	The initial induction dose is 6.0mg/kg, with a dose gradient of 0.5mg/kg (range: 4.0-8.0mg/kg). Sedation success is defined as a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤3 within 3 minutes after drug administration. Dose adjustment follows the k=3 sequential design: ① 3 consecutive successes → next patient receives a 0.5mg/kg lower dose; ② 1 failure → next patient receives a 0.5mg/kg higher dose; ③ 2 consecutive failures → skip the next gradient. Immediately after successful induction (MOAA/S ≤3 within 3 minutes), continuous infusion of fospropofol disodium for sedation maintenance will be initiated. The initial maintenance rate is 6.0mg/kg/h, with a gradient of 0.5mg/kg/h (range: 3.0-7.5mg/kg/h). Maintenance success is defined as MOAA/S score ≤3 in ≥4 of 6 assessments (once every 10 minutes). Dose adjustment follows the k=3 sequential design: ① 3 consecutive successes → next patient receives a 0.5mg/kg/h lower rate; ② 1 failure → next patient receives a 0.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2027-03-01
• First posted: 2026-01-12
• Last updated: 2026-01-13

Locations

1 site across 1 country: China