RecruitingNot ApplicableNCT06732427

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

Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled Trial


Sponsor

Affiliated Hospital of Nantong University

Enrollment

426 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Propofol and a drug called fospropofol Disodium for injection for people with efficacy and safety. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGfospropofol Disodium for injection

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

DRUGPropofol

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


Locations(5)

Hai 'an People's Hospital

Hai’an, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Qidong People's Hospital

Qidong, Jiangsu, China

Rudong County Hospital of Traditional Chinese Medicine

Rudong, Jiangsu, China

Rugao People's Hospital

Rugao, Jiangsu, China

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NCT06732427


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