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 range50 Years – 65 Years
SexALL
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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;
✕. Patients with pathological obesity / obstructive sleep apnea, patients with difficult respiratory tract management;
✕. Acute upper respiratory tract infection and asthma attacks;
✕. Liver and kidney insufficiency, abnormal heart function;
✕. History of mental disorders, long-term use of analgesics; history of drug addiction and drug use;
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