Actively Recruiting
Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial
Led by Hui Xu · Updated on 2025-04-16
373
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery. The study has three main objectives: First, to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia; Secondly, to evaluate the efficacy and safety of fospropofol disodium in the maintenance phase of general anesthesia, and to determine its effective dose range; Finally, the effects of fospropofol disodium on Bispectral Index during induction, maintenance and recovery were studied, and compared with propofol to understand its characteristic changes. The randomized, single-blind, controlled design of the study, with an expected enrollment of 373 patients, was designed to achieve its objectives through a three-phase trial design to provide important clinical information about the safety and efficacy of the use of propofol disodium.
CONDITIONS
Official Title
Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- American Society of Anesthesiologists (ASA) grade I or II
- Scheduled for laparoscopic abdominal surgery under general anesthesia with estimated operation time over 3 hours
- Body mass index (BMI) between 18 and 30 kg/m2
- Voluntarily signed informed consent
You will not qualify if you...
- Contraindications to general anesthesia or history of anesthesia accidents
- History of brain injury, intracranial hypertension, stroke, unstable angina, or myocardial infarction
- Respiratory insufficiency, obstructive pulmonary disease, difficult airway, or difficult tracheal intubation (modified Markov score III or IV)
- Uncontrolled diabetes or high blood pressure
- History of drug use, alcoholism, or drug dependence
- Abuse or long-term use of narcotic, sedative, or analgesic drugs
- Known or suspected allergies to study drug components (sufentanil citrate, propofol milk, remifentanil, propofol disodium)
- History of mental illness
- Participation in any drug clinical trial within 1 month before screening
- Pregnant or lactating women; unwillingness to use contraception during the trial; planning pregnancy within 3 months after the trial
- Any other factors deemed unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
T
Tao Hong, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here