Tongji Hospital
Wuhan, Hubei, China
Location status: Recruiting
NCT Number: NCT06573489
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 4
Wuhan, Hubei, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use fospropofol for general anesthesia maintenance
Other names: fospropofol disodium
Use propofol for general anesthesia maintenance
Other names: Diprivan propofol
Time frame: From the beginning to the end of surgery
Incidence of hypotension throughout perioperative period
Time frame: During induction of anesthesia
Incidence of perceived injection pain during anesthesia induction
Time frame: First day after surgery
The patients' glomerular filtration rate
Time frame: From the beginning to the end of surgery
Eeg dual frequency index waveform during operation
Time frame: First day after surgery
Blood level of urea nitrogen
Time frame: First day after surgery
Blood level of creatinine
Contact information is provided by the study sponsor or research team.
Hui Xu
Other
Minimum Effective Dose and Maintenance Effectiveness of Fospropofol for General Anesthesia Induction in Adult Laparoscopic Abdominal Surgery: A Randomized, Single-Blind, Clinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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