Fospropofol for painless gastrointestinal endoscopy and colonoscopy
Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled Trial
This trial tests whether fospropofol provides safer, more stable, and more comfortable anesthesia than propofol for adults aged 50–65 having painless gastrointestinal endoscopy or colonoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 426 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 5 sites (Hai’an, Jiangsu and 4 other locations) |
| Trial ID | NCT06732427 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, double-blind, controlled trial comparing fospropofol disodium to propofol for painless endoscopic diagnosis and treatment. Eligible patients (age 50–65, weight 40–65 kg, ASA I–II) are assigned by computer-generated randomization to either the fospropofol group or the propofol group, with drug administration performed by designated anesthesiologists. The study measures anesthesia induction and intraoperative respiratory and circulatory stability, rates of hypoxemia and adverse cardiovascular events, recovery profile, and common adverse effects such as injection pain and postoperative nausea and vomiting. The planned duration of the project exceeds two years and is conducted at multiple hospitals in Jiangsu Province, China.
Who should consider this trial
Good fit: Adults aged 50–65 years, weighing 40–65 kg, with ASA physical status I–II who are scheduled for painless gastrointestinal endoscopy or colonoscopy and can give informed consent are ideal candidates.
Not a fit: Patients with obesity or obstructive sleep apnea, difficult airways, acute respiratory infections, significant liver or kidney impairment, abnormal cardiac function, drug allergies, or other listed exclusion criteria are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, fospropofol could offer more stable anesthesia with fewer respiratory and cardiovascular complications, less injection pain, and faster recovery for patients undergoing painless endoscopy.
How similar studies have performed: Previous clinical work with fospropofol for procedural sedation has shown some benefits such as reduced injection pain and comparable sedative efficacy to propofol, but its use is less widespread and data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 50-65 years, weight 40-65kg, male or female; 2. Patients undergoing painless gastrointestinal endoscopy or painless colonoscopy; 3. American Society of Anesthesia (ASA) grades I-II; 4. Patients and their families can understand and fill in various rating scales, and voluntarily sign the informed consent form; - Exclusion Criteria: 1. Patients with simple and painless gastroscopy 2. Allergy to this study drug and any ingredients; 3. Patients with pathological obesity / obstructive sleep apnea, patients with difficult respiratory tract management; 4. Acute upper respiratory tract infection and asthma attacks; 5. Liver and kidney insufficiency, abnormal heart function; 6. History of mental disorders, long-term use of analgesics; history of drug addiction and drug use; 7. Do not voluntarily cooperate with the patient or be unsuitable by the investigator to participate in the trial.-
Where this trial is running
Hai’an, Jiangsu and 4 other locations
- Hai 'an People's Hospital — Hai’an, Jiangsu, China (Recruiting)
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
- Qidong People's Hospital — Qidong, Jiangsu, China (Not_yet_recruiting)
- Rudong County Hospital of Traditional Chinese Medicine — Rudong, Jiangsu, China (Recruiting)
- Rugao People's Hospital — Rugao, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Xiao MB Director of scientific research Department, Doctor — Affiliated Hospital of Nantong University
- Study coordinator: Gao YT Director of Department of Anesthesiology, Master
- Email: gyt19700114@sina.com
- Phone: +86 13962988003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.