Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment
Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled Trial
Affiliated Hospital of Nantong University
426 participants
Aug 12, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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.-
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Interventions
Group L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds)
Group B received slow intravenous sufentanyl 0. 1 ug / kg +propofol 2mg / kg (completed within 60 seconds)
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06732427