Hepatic Impairment
Conditions
Interventions
Hepatic Impairment :fospropofol disodium for injection
Healthy:fospropofol disodium for injection
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients undergoing painless endscopy or treatment under gerenal anssthesia; 2.Male and female subjects aged 18-65 y with BMI of 18-30 kgm2 inclusive were eligible. 3.Hepatically impaired subject :Degree of hepatic impairment will be determined by the Child-Pugh Scale ;Healthy subjects were matched to their respective hepatically impaired subject with respect to sex, age, and BMI. Age was allowed to deviate within a range of plus or minus 5 yr and BMI within plus or minus 15%; 4.Understanding the process and methods of research,and voluntarily sign informed consent
Exclusion criteria
Exclusion criteria: 1.Clinical manifestation of any disease except hepatic impaired subjects,for example, severe renal insufficiency; 2.Difficulty in ventilation or intubation is expected(Modified Mallampati III-IV); 3.Patients who consumed alcohol within 48 hours ; 4.History of drug and alcohol abuse ,drug dependence; 5.a history of mental illness; 6.Participation in any other investigational drug trial in which an investigational drug was used within 28 days; 7.Gestation period or patients who decline the use of contraception are frequently observed. 8.the pre-trial screening assessment that the investigator judged as likely to interfere with the objectives of the trial or the safety of the volunteer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;Loss of consciousness;Changes in BIS;The disappearance of eyelash reflections;Endoscopist's satisfaction score on anesthesia induction and maintenance; | — |
Countries
CHINA
Contacts
Public ContactWEIYI ZHANG
West China Hospital of Sichuan University
Outcome results
None listed