Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Tre… (NCT06732427) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment
China426 participantsStarted 2025-08-12
Plain-language 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.
Who can participate
Age range
50 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 50-65 years, weight 40-65kg, male or female;
. Patients undergoing painless gastrointestinal endoscopy or painless colonoscopy;
. American Society of Anesthesia (ASA) grades I-II;
. Patients and their families can understand and fill in various rating scales, and voluntarily sign the informed consent form; -
Exclusion criteria
. Patients with simple and painless gastroscopy
. Allergy to this study drug and any ingredients;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sedation success rate
Timeframe: At 5 minutes after anesthetic administration
2
Length of successful induction of anesthesia
Timeframe: During anesthesia
3
hypoxaemia
Timeframe: During anesthesia
Trial details
NCT IDNCT06732427
SponsorAffiliated Hospital of Nantong University
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-06-30
Contact for this trial
Gao YT Director of Department of Anesthesiology, Master