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RECRUITING
NCT06573489
PHASE4

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

Sponsor: Hui Xu

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

373

Start Date

2024-09-15

Completion Date

2026-07-01

Last Updated

2025-04-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

Fospropofol

Use fospropofol for general anesthesia maintenance

DRUG

Propofol

Use propofol for general anesthesia maintenance

Locations (1)

Tongji Hospital

Wuhan, Hubei, China