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Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment

NCT06732427 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2025-09-30

No results posted yet for this study

Summary

This is a study on the efficacy and safety of fospropofol disodium for injection in painless endoscopic diagnosis and treatment, project No.2024-YCRF-M1021, which will take more than 2 years to complete.

This is a multicenter, randomized, double-blind, controlled clinical study. Using a computer-generated randomized number table, the patients were divided into two groups: the group L (fospropofol disodium group) and the group B (propofol group). After determining the group of enrolled patients, the drug was administered by two fixed anesthesiologists By participating in this study, it is possible to make your anesthesia induction stable, stable intraoperative circulation, awake and safe and comfortable, to reduce the incidence of intraoperative hypoxemia, intraoperative awareness, cardiovascular and cerebrovascular malignant events (malignant arrhythmia, cardiac arrest), which is conducive to your rapid postoperative recovery and reduce hospitalization costs.

Conditions

  • Efficacy and Safety

Interventions

DRUG

fospropofol Disodium for injection

Group L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds)

DRUG

Propofol

Group B received slow intravenous sufentanyl 0. 1 ug / kg +propofol 2mg / kg (completed within 60 seconds)

Sponsors & Collaborators

  • Rugao People's Hospital

    collaborator OTHER

  • Qidong People's Hospital

    collaborator UNKNOWN

  • Hai 'an People's Hospital

    collaborator UNKNOWN

  • Rudong County Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Affiliated Hospital of Nantong University

    lead OTHER

Principal Investigators

  • Xiao MB Director of scientific research Department, Doctor · The Affiliated Hospital of Nantong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

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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 NCT06732427 on ClinicalTrials.gov