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Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment
Sponsor: Affiliated Hospital of Nantong University
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
Conditions
Interventions
fospropofol Disodium for injection
Group L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds)
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