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.
1. To explore the lowest effective dose of fospropofol disodium for general anesthesia induction in adult laparoscopic abdominal surgery 2. Observation on efficacy, safety and effective dose range of propofol disodium for general anesthesia maintenance in adult laparoscopic abdominal surgery 3. To study the changes of Bispectral Index in the brain of patients treated with propofol during induction, maintenance and recovery of general anesthesia during laparoscopic abdominal surgery in adults, and to compare with BIS(Bispectral Index) monitoring under propofol, and to study the characteristic changes of BIS(Bispectral Index) waveform in patients treated with propofol disodium.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
373
Use fospropofol for general anesthesia maintenance
Use propofol for general anesthesia maintenance
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGIncidence of perioperative hypotension
Incidence of hypotension throughout perioperative period
Time frame: From the beginning to the end of surgery
Incidence of injection pain
Incidence of perceived injection pain during anesthesia induction
Time frame: During induction of anesthesia
Glomerular filtration rate
The patients' glomerular filtration rate
Time frame: First day after surgery
Eeg dual frequency exponential waveform
Eeg dual frequency index waveform during operation
Time frame: From the beginning to the end of surgery
Urea nitrogen
Blood level of urea nitrogen
Time frame: First day after surgery
Creatinine
Blood level of creatinine
Time frame: First day after surgery
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