About this trial
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.
Eligibility criteria
Qualifiers
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; -
Disqualifiers
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;
Trial design
Treatments tested in this trial
- fospropofol Disodium for injection
- Propofol
Treatment groups
Sponsors and collaborators
Affiliated Hospital of Nantong University
Lead sponsor
Rugao People's Hospital
Collaborator
Qidong People's Hospital
Collaborator
Hai 'an People's Hospital
Collaborator
Rudong County Hospital of Traditional Chinese Medicine
Collaborator