Actively Recruiting
Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled Trial
Led by Affiliated Hospital of Nantong University · Updated on 2025-09-30
426
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
Affiliated Hospital of Nantong University
Lead Sponsor
R
Rugao People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of fospropofol disodium for injection during painless endoscopic diagnosis and treatment, including gastrointestinal endoscopy and colonoscopy, in adults aged 50 to 65 years. This multicenter, randomized, double-blind, controlled clinical study compares fospropofol disodium with propofol to find an appropriate anesthesia method that improves patient comfort, stabilizes anesthesia induction, and reduces adverse events like hypoxemia and cardiovascular complications. Participants are randomly assigned to one of two groups: one receives slow intravenous sufentanyl plus fospropofol disodium at 8 mg/kg completed within 60 seconds, and the other receives slow intravenous sufentanyl plus propofol at 2 mg/kg completed within 60 seconds. Two fixed anesthesiologists administer the drugs. The study focuses on sedation success, anesthesia induction duration, and incidence of hypoxemia, among other safety and effectiveness measures. During the trial, participants undergo painless gastrointestinal procedures while researchers monitor sedation success, total drug doses, intraoperative vital signs, body movements, injection pain, and recovery quality at intervals up to 30 minutes after awakening. The study also tracks hemodynamic stability and adverse reactions to assess the overall safety profile. The total study duration exceeds two years, with careful follow-up to support rapid recovery and reduce hospitalization costs.
CONDITIONS
Brief Title
Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 to 65 years, weight 40 to 65 kg, 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 will not qualify if you...
- Patients with simple and painless gastroscopy
- Allergy to this study drug and any ingredients
- Patients with pathological obesity or obstructive sleep apnea, or with difficult respiratory tract management
- Acute upper respiratory tract infection and asthma attacks
- Liver and kidney insufficiency or abnormal heart function
- History of mental disorders, long-term use of analgesics, history of drug addiction or drug use
- Patients unwilling to cooperate or deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants receive anesthesia with either fospropofol disodium or propofol for painless gastrointestinal endoscopy or colonoscopy procedures. The treatment involves administration of study drugs by intravenous injection and monitoring during the procedure.
1 treatment visit (in-person)
Duration - Up to 30 minutes after awakening
Participants are observed after anesthesia to assess recovery quality, wake-up time, and any adverse reactions related to the anesthesia.
1 follow-up visit (in-person)
Trial Site Locations
Total: 5 locations
1
Hai 'an People's Hospital
Hai’an, Jiangsu, China, 226600
Actively Recruiting
2
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
3
Qidong People's Hospital
Qidong, Jiangsu, China, 226200
Not Yet Recruiting
4
Rudong County Hospital of Traditional Chinese Medicine
Rudong, Jiangsu, China, 226400
Actively Recruiting
5
Rugao People's Hospital
Rugao, Jiangsu, China, 226500
Actively Recruiting
Research Team
G
Gao YT Director of Department of Anesthesiology, Master
L
Liu YF project implementation PI, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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