Induction of general anesthesia
Conditions
Interventions
Control group (Propofol):The subjects received a bolus IV injection of 2 mg
Experimental group(Fospropofol disodium):The subjects received a bolus IV injection of 20 mg/kg fospropofol disodium
Sponsors
Yichang HumanWell Pharmaceutical Co.,Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-65 years, with the Body Mass Index (BMI) of 18-30 kg/m2; 2. American Society of Anesthesiologists (ASA) physical status of P1 to P2; 3. Patients scheduled to undergo a selective operation under a general anesthesia, where the operation time 3 h, and the bleeding volumn <=400 ml; 4. Systolic blood pressure (SBP) 90-140 mmHg, with diatolic blood pressure (DBP) <=90 mmHg; 5. Normal ECG or abnormal ECG without clinical significance, such as heart rate 50-120 beats per minute (bpm), QTc interval (a corrected QT interval by the Bazetts formula) <=450 ms in the male volunteers or <=470 ms in the female volunteers; 6. Normal results of hepatic or renal functions or abnomal results without clinical significance.
Exclusion criteria
Exclusion criteria: 1. Known allergic diseases or hypersensitivity to the drugs with similar structure to the study drug; 2. Family history of malignant hyperthermia; 3. Pregnancy or having pregnancy plan within 1 month; 4. Any contraindication to the study drug; 5. Presence of primary or secondary hypertension, central nervous system diseases or coagulation disorders; 6. Presence of a known or expected difficult airway; 7. History of a surgery under a general anesthesia within 3 months; 8. History of alcohol, drugs, or medication abuse; 9. Participation in an investigational drug study within 3 months; 10. Previous exposure to some QT-prolongation drugs within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction success rate within 5 minutes after administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Induction success rate within 25 minutes after administration;Supplemental rate of the study drug;Time to MOAA/S score of 1;Time to disappearance of eyelash reflex;Bispectral index (BIS);Response to Pain stimulation;Reaction of intubation and extubation;Time to recovery; | — |
Countries
China
Contacts
Public ContactJin Liu
Outcome results
None listed