It is intended for endotracheal intubation and maintenance of skeletal muscle relaxation during induction of general anesthesia
Conditions
Interventions
A1:A total of 12 volunteers were included in group A1. Each volunteer received two doses of the first dose of 0.2 to 0.3 mg/kg, about 5±1 s intravenously. The second dose was 0.75 mg/kg and 30±1 s int
A2:Ten volunteers were planned to be included in the A2 group, and each volunteer received a dose of 0.75 mg/kg with intravenous injection of 60±1 s.
B1:Ten volunteers were planned to be included in group B1, and each volunteer received a dose of 1.0 mg/kg with intravenous infusion of about 30±1 s.
B2:Ten volunteers were planned to be included in the B2 group, each of which received a dose of 1.0 mg/kg and intravenous injection of about 60±1 s.
C1:Ten volunteers were planned to be included in group C1, each of which received a dose of 1.25 mg/kg and intravenous infusion of about 30±1 s.
C2:Ten volunteers were scheduled to be included in the C2 group, each receiving a dose of 1.25 mg/kg and intravenous infusion of about 60±1 s.
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: To be eligible, all criteria are met: 1) Age 18 to 45 (including boundary value), both male and female; 2)ASA grade ?; 3) Male weight =50 kg, female weight =45 kg, body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values); 4) The volunteer has no sperm or egg donation plan within 3 months after signing the informed consent and administering the medicine, and voluntarily adopts efficient and reliable contraceptive methods to avoid pregnancy of the female volunteer or pregnancy of the male volunteer's partner; Before the trial, the volunteers had a detailed understanding of the nature, significance, possible benefits, possible inconvenience and potential risks and discomfort of the trial. They could understand the procedures and methods of the study, were willing to strictly abide by the requirements of the entire clinical study, and voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: Compliance with 1 of these rules is excluded: 1) Patients with past or current clinical acute or chronic diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, which researchers determine may significantly affect the pharmacokinetic characteristics or safety evaluation of investigational drugs; 2) People with a history of neuromuscular diseases (such as myotonic dystrophy, poliomyelitis, myasthenia gravis, botulism) or poliomyelitis; 3) Patients with a history of anesthesia complications; 4) Patients with a history of asthma or airway diseases requiring treatment; 5) Patients with a history of anatomic airway abnormalities, or signs of airway abnormalities assessed during screening airway examinations, which may affect laryngoscope placement or tracheal intubation; 6) Patients with a history or family history of malignant hyperthermia, or those susceptible to malignant hyperthermia (congenital diseases such as idiopathic scoliosis, strabismus, ptosis, umbilical hernia, inguinal hernia, etc.); 7) People with any history of allergies or specific allergic diseases (such as allergic asthma, urticaria, eczema, etc.); 8) Patients who received heavy surgery within 3 months (90 days) before screening; 9) Patients who have undergone surgery that may significantly influence the pharmacokinetic profile or safety evaluation of the investigational drug product, or who plan to undergo surgery during the study period; 10) Receiving antihistamines or antidepressants within 3 months (90 days) prior to screening; 11) Any drug that inhibits or induces liver metabolism of drugs (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) used within 30 days prior to administration; Inhibitors -- SSris antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 12) Vaccinated within 30 days prior to administration; 13) Have used any medicine or health product (including Chinese herbal medicine) in the 14 days prior to administration; 14) Those whose screening period is known to be likely to require other medications during the study; 15) Have used any investigational drug within 3 months (90 days) prior to screening, or plan to participate in other clinical trials during the study period; 16) Blood donation/loss =400 mL (except for female physiologic blood loss) within 3 months (90 days) prior to screening, receiving transfusion or using blood products, or planning to donate blood during the trial or within 1 month after the trial; 17) Those who smoked more than 5 cigarettes per day in the 3 months (90 days) before screening, or could not quit during the trial; 18) Regular drinkers (averaging more than 14 units of alcohol per week, 1 unit =360 mL beer or 45 mL 40% spirits or 150 mL wine) during the 3 months (90 days) prior to screening, or who cannot stop drinking during the trial; 19) Excessive consumption of tea, coffee or caffeinated beverages (mean more than 8 cups per day, 1 cup =200 mL) during the 3 months (90 days) prior to screening; 20) Eat special food (such as grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeinated food or drink) within 48 hours before administration; 21) Those who have special dietary requirements and cannot abide by the unified di
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of maximum T1 inhibition;The maximum T1 inhibition time was reached;Onset time;Action time;Recovery rate;Vital signs;Physical Examination;Laboratory tests;12-lead electrocardiogram;Adverse Events;Blood concentration; | — |
Countries
China
Contacts
Public ContactWen OUYANG/Guoping YANG
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Outcome results
None listed