NCT06344325

ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia

90% Effective Dose Study of Fospropofol Disodium in Induction and Maintenance of Anesthesia in Adults of Different Ages

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia

Detailed description

As a newly marketed sedative hypnotic agent, fospropofol disodium is currently the only water-soluble precursor drug of propofol in China. It has the characteristics of long duration of action, low incidence of injection pain, respiratory and circulatory system related adverse events, and no lipid metabolism related adverse reactions, providing anesthesiologists with another sedative option during surgery. However, there are currently few clinical observation studies on this drug, and there have been no reports on its effective dosage in different age groups. Therefore, this study aims to observe the 90% effective dose (ED90) in anesthesia induction and maintenance in adults of different ages, providing effective clinical evidence for its application in clinical anesthesia.

Conditions

• Elective Surgery

Interventions

Type	Name	Description
DRUG	fospropofol	The initial dose of fospropofol disodium in the youth group is 15mg/kg,the middle-aged group is 10mg/kg, the elderly group is 7.5mg/kg, and the concentration of adjacent intervals is 0.5mg/kg.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2024-04-03
• Last updated: 2025-08-14

Locations

1 site across 1 country: China