Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment
Recruiting now · Not applicable
Conditions studied: Efficacy and Safety
In brief
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.
Key facts
- Study ID
- NCT06732427
- Run by
- Affiliated Hospital of Nantong University
- People needed
- 426
- Starts
- 2025-08-12
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-09-30
Who can join
Age: 50 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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; -
You may not qualify if…
- 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;
- Do not voluntarily cooperate with the patient or be unsuitable by the investigator to participate in the trial.-
Where it is running
- Hai 'an People's Hospital — Hai’an, Jiangsu, China (enrolling)
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (enrolling)
- Rudong County Hospital of Traditional Chinese Medicine — Rudong, Jiangsu, China (enrolling)
- Rugao People's Hospital — Rugao, Jiangsu, China (enrolling)
- Qidong People's Hospital — Qidong, Jiangsu, China
Full record on ClinicalTrials.gov
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