Actively Recruiting
Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment
Led by Affiliated Hospital of Nantong University · Updated on 2025-09-30
426
Participants Needed
5
Research Sites
72 weeks
Total Duration
On this page
Sponsors
A
Affiliated Hospital of Nantong University
Lead Sponsor
R
Rugao People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 to 65 years, weight 40 to 65 kg, male or female
- Undergoing painless gastrointestinal endoscopy or painless colonoscopy
- American Society of Anesthesia (ASA) grades I-II
- Ability to understand and complete rating scales and voluntarily sign informed consent
You will not qualify if you...
- Patients with simple and painless gastroscopy
- Allergy to the study drug or any of its ingredients
- Patients with pathological obesity, obstructive sleep apnea, or difficult airway management
- Acute upper respiratory tract infection or asthma attacks
- Liver and kidney insufficiency or abnormal heart function
- History of mental disorders, long-term analgesic use, drug addiction, or drug use
- Unwillingness or unsuitability to cooperate with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hai 'an People's Hospital
Hai’an, Jiangsu, China, 226600
Actively Recruiting
2
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
3
Qidong People's Hospital
Qidong, Jiangsu, China, 226200
Not Yet Recruiting
4
Rudong County Hospital of Traditional Chinese Medicine
Rudong, Jiangsu, China, 226400
Actively Recruiting
5
Rugao People's Hospital
Rugao, Jiangsu, China, 226500
Actively Recruiting
Research Team
G
Gao YT Director of Department of Anesthesiology, Master
CONTACT
L
Liu YF project implementation PI, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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