not any specific disease, but referring to the induction and maintenance of general anesthesia
Conditions
Interventions
Study group 1 (fospropofol group 1, bolus dose 15 mg/kg followed by initial infusion rate at 10 mg/kg/kg):Study Group 1: bolus intravenous injection of fospropofol at 15 mg/kg, followed by intravenou
Study Group 2 (fospropofol group 2, bolus dose 15 mg/kg followed by initial infusion rate at 15 mg/kg/kg):Study Group 2: bolus intravenous injection of fospropofol at 15 mg/kg, followed by intravenou
Control Group (Propofol group):Control group: bolus intravenous injection of propofol at 2 mg/kg, followed by intravenous infusion of propofol at initial rate of 6 mg/kg/h, n=18, in which 6 subjects r
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 45 years old, healthy Chinese males and females; 2. Body weight =50.0 kg for males and =45.0 kg for females; Body Mass Index (BMI) between 19.0 and 26.0 kg/m^2 (BMI = weight [kg] / height^2 [m^2]), including the boundary values; 3. Subjects commit to the following: neither the subject nor their spouse plan to conceive from the signing of the informed consent, during the period of using the investigational product, and up to 6 months after discontinuation of the product, and they voluntarily agree to use effective contraceptive measures. 4. Fully aware of the nature, significance, potential benefits, possible inconvenience, and potential risks of the study, comprehend the research procedures, and voluntarily sign a written informed consent form before participated in the trial; 5. Be able to communicate effectively with the researchers and complete the study in accordance with the provisions of the research protocol.
Exclusion criteria
Exclusion criteria: 1. Known allergy to fospropofol disodium and its dissolvent (mannitol), or propofol; or having contraindications to anesthetic drugs; 2. Suspected history of malignant hyperthermia inheritance; 3. Modified Mallampati score =3; 4. Pregnant or lactating females; 5. History of, or currently suffering from, any clinically significant diseases of the cardiovascular, endocrine, central nervous, liver/kidney, respiratory, hematologic, immune, psychiatric, and metabolic systems, or any other diseases that, in the researcher's judgment, could interfere with the trial results; 6. Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg, heart rate 100 bpm, oxygen saturation <95%) or significant abnormalities in physical examination, 12-lead electrocardiogram, or laboratory tests (as determined by a physician); 7. History of drug abuse, substance misuse, and long-term medication use; 8. Alcoholism or frequent alcohol consumption within 6 months prior to the trial, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine), or inability to abstain from any alcohol-containing products 48 hours before the trial; 9. Smoking more than 5 cigarettes per day within 3 months prior to the trial, or inability to quit smoking 48 hours before the trial; 10. Participation in any clinical trial and receiving intervention within 3 months prior to the trial, or blood donation or blood loss = 200 mL within 3 months (including blood collection for clinical trials) prior to the trial; 11. History of any surgery within 1 month prior to the trial, or planning to undergo surgery; 12. Use of any medication or dietary supplements (including herbal remedies) within 14 days prior to the trial; 13. Consumption of special diets (such as grapefruit and products containing grapefruit, chocolate, any caffeine-containing, or purine-rich foods like animal liver) or vigorous exercise within 48 hours prior to the trial, or other factors that may affect drug absorption, distribution, metabolism, or excretion; 14. Daily consumption of excessive tea, coffee, and/or caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) or inability to adhere to the dietary plan of the trial; 15. Any other reason deemed unsuitable for participation in this study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristics;Pharmacodynamic characteristics; | — |
Countries
China
Contacts
Public ContactYin Qinqin, Miao Jia
West China Hospital, Sichuan University
Outcome results
None listed