MedTrace Logo

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

NCT06573489 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 373

Last updated 2025-04-16

No results posted yet for this study

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.

Conditions

  • Drug Safety

Interventions

DRUG

Fospropofol

Use fospropofol for general anesthesia maintenance

DRUG

Propofol

Use propofol for general anesthesia maintenance

Sponsors & Collaborators

  • Hui Xu

    lead OTHER

Principal Investigators

  • Tao Hong, Master · Tongji Hospital, Tongji Medical College, Huazhong University of Scien

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2025-10-01
Completion
2026-07-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06573489 on ClinicalTrials.gov