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RECRUITING
NCT06732427
NA

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

Sponsor: Affiliated Hospital of Nantong University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

426

Start Date

2025-08-12

Completion Date

2026-12-31

Last Updated

2025-09-30

Healthy Volunteers

No

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)

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