NCT06573489

Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial

Minimum Effective Dose and Maintenance Effectiveness of Fospropofol for General Anesthesia Induction in Adult Laparoscopic Abdominal Surgery: A Randomized, Single-Blind, Clinical Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 373 (estimated)
• Sponsor: Hui Xu · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery. The study has three main objectives: First, to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia; Secondly, to evaluate the efficacy and safety of fospropofol disodium in the maintenance phase of general anesthesia, and to determine its effective dose range; Finally, the effects of fospropofol disodium on Bispectral Index during induction, maintenance and recovery were studied, and compared with propofol to understand its characteristic changes. The randomized, single-blind, controlled design of the study, with an expected enrollment of 373 patients, was designed to achieve its objectives through a three-phase trial design to provide important clinical information about the safety and efficacy of the use of propofol disodium.

Detailed description

1. To explore the lowest effective dose of fospropofol disodium for general anesthesia induction in adult laparoscopic abdominal surgery 2. Observation on efficacy, safety and effective dose range of propofol disodium for general anesthesia maintenance in adult laparoscopic abdominal surgery 3. To study the changes of Bispectral Index in the brain of patients treated with propofol during induction, maintenance and recovery of general anesthesia during laparoscopic abdominal surgery in adults, and to compare with BIS（Bispectral Index） monitoring under propofol, and to study the characteristic changes of BIS（Bispectral Index） waveform in patients treated with propofol disodium.

Conditions

• Drug Safety

Interventions

Type	Name	Description
DRUG	Fospropofol	Use fospropofol for general anesthesia maintenance
DRUG	Propofol	Use propofol for general anesthesia maintenance

Timeline

• Start date: 2024-09-15
• Primary completion: 2025-10-01
• Completion: 2026-07-01
• First posted: 2024-08-27
• Last updated: 2025-04-16

Locations

1 site across 1 country: China